Pfizer

I received the COVID-19 Vaccination in 12-29-2020. As time went on, I felt a little flushed , Lightheaded , some dizziness that night. Forced the water intake. 12-30-2020, went to work, as the day went on the rash on my face and neck into upper chest increased and Hypertension. I went to the ER Dept at Hospital. IV Fluids and IV Benadryl and oral Prednisone and Prednisone to be taken at home. Face and neck rash goes away and comes back as of Jan 1 2021.

Dizziness, nausea, sweating, throat swelling, hard to swallow, dry mouth, headache, shaky, feeling hot/cold

* Had sore arm at the vaccine site * Headache began at 7 pm on 3-Jan * Had chills during the night, cold and unable to get warm even with multiple blankets * Severe dizziness and vomiting * Headache not relieved by Ibuprofen; took 25 mg Benadryl at midnight

Employee received the vaccine around 1130. She was monitored for a least 30 minutes due to her history of CA and Immunosupressed state. She went back to her office post monitoring. Around 1535, one of her employees called reporting that she didn't look good and was acting weird - pale; stumbling; slurred speech. The coworker brought employee to the immunization clinic in private vehicle. Dr. along with the CNE and another RN went to the vehicle to asses. It was noted that employee did have slurred/slow speech; droopiness to face. She reported that she started to not feel well while in her office. V/S: B/P 141/102; pulse 108; O2 sat 96% on RA; skin pale. She stated that she felt "loopy". Employees husband was called and her co-worker was instructed to take the employee to the ER where her husband would meet them. At 1540, employee was taken to ER for evaluation.

Palpitations; Weakness; sore throat; Burning sensation and the soreness in tongue; Burning sensation and the soreness in tongue; vomiting severely 5 times; could not eat and breathe; could not eat and breathe; abdomen was upset; cramps and pain; cramps and pain; diarrhea; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the receive bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EK5730), via an unspecified route of administration on 21Dec2020 at 60-years-old at a single dose for COVID-19 immunization. Medical history included high cholesterol from an unknown date and unknown if ongoing. Concomitant medications included rosuvastatin calcium (CRESTOR) taken for high cholesterol from an unspecified date to an unspecified date. The patient experienced the following events and outcomes: palpitations (non-serious) on 22Dec2020 with outcome of unknown , weakness (non-serious) on 22Dec2020 with outcome of unknown, sore throat (non-serious) on 22Dec2020 with outcome of unknown, burning sensation and the soreness in tongue (non-serious) on 22Dec2020 with outcome of unknown, vomiting severely 5 times (non-serious) in Dec2020 with outcome of unknown, could not eat and breathe (non-serious) in Dec2020 with outcome of unknown, abdomen was upset (non-serious) in Dec2020 with outcome of unknown, cramps and pain (non-serious) in Dec2020 with outcome of unknown, diarrhea (non-serious) in Dec2020 with outcome of unknown. The nurse stated she received the COVID vaccine on 21Dec2020. The nurse stated she did not have any adverse reaction immediately on the first day but on the second day, after 24 hours, she started to have "little bit palpitations that too for a short period of time and a little bit weakness for a short period of time and sore throat. It is not just soring or swelling but it is burning sensation and, on my tongue, also I feel the same thing, burning sensation and the soreness. That was for a small period of time but on my tongue, it is still there, and my throat is still there and last night I experienced vomiting severely 5 times. After the vomiting, I could not eat and breathe." Then, the nurse slept about 3-5 hours, and woke up and her abdomen was upset. The nurse had cramps and pain and when she went to the bathroom and she had huge diarrhea, 2 times."

Patient experienced a bit of flushing, itchiness in nose, eyes, tingling in mouth/scalp, and a little throat tightness after initial monitoring period of 15 minutes. Occurred 1-2 hours after dose admin. Resolved with no treatment, though Benadryl was recommended.

Rhinorrhea; Fever; Injection site pain; Chills; facial flushing; This is a spontaneous report from a non-contactable other-HCP (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK9231) (Brand= Pfizer), via an unspecified route of administration on 24Dec2020 07:15AM at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. The facility type vaccine was workplace clinic. None medical history. The patient's concomitant medications was not reported. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The known allergies included Ibuprofen based pain medicine. On 24Dec2020, patient experienced injection site pain; chills; facial flushing. 25Dec2020 fever. 26Dec2020 rhinorrhea. Patient didn't receive treatment for the adverse events. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was recovered in Dec2020. No follow-up attempts are possible. No further information is expected.

Some swelling of arm; Rash developed 5cm x 4cm at injection site; Chills and shivers; Bronchospasm cough; Bronchospasm cough; Mild eczema flare ups, itchiness and sores; Mild eczema flare ups, itchiness and sores; Mild eczema flare ups, itchiness and sores; Spasm; she has a lot of allergies; This is a spontaneous report from a contactable nurse. This 60-year-old female nurse (patient) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 to 23Dec2020 at 0.3 mL single on left deltoid to prevent getting the COVID vaccine, for protection. Medical history included ongoing asthma diagnosed in her mid twenties, in the 80s, she had asthma when she was a child, then it stopped and resurfaced in her mid twenties, ongoing eczema diagnosed years already, a long time ago and unspecified allergies with medications. There were no concomitant medications. She received the vaccine on 23Dec2020. She has a lot of allergies in Dec2020, and had some side effects, and she got through it ok. Her side effects were some swelling of arm, a rash developed, like 5cm x 4cm at site of injection, chills and shivers, and a bronchospasm cough on 24Dec2020. Arm swelling event started 24 hours later, no more, it was stable for 24 hours, and the 3rd day, went down, was a little raised, the next day was flat but still red. She had recovered completely. The 4th day was a good day. The patient stated she had some allergy shots she had to go through before, this was no different. Rash was no more, it was gone by 27Dec2020. She was still able to go to work. Chills and shivers started 24 hours later, and took for 48 hours intermittently, she had since recovered completely. The patient stated this was all nothing different than getting like the flu shot. Bronchospasm cough event only took another 48 hours, the difference was, even when she calls it bronchospasm, it was close to when she had an asthma attack, but no chest tightness, shortness of breath, she just would cough, spasm in Dec2020 and stop. She had recovered completely. The patient stated she had no symptoms at all before the vaccine, she was healthy, she made sure nothing was going on, that she was not tired, had no cold, she took no medications for this, as she wanted to know how her body reacted and if it can handle it. They says it was ok to take paracetamol (TYLENOL), but she did not, but the second dose she would, now that she knows and she was comfortable through it. She did have some mild eczema flare ups, itchiness and sores that came up in Dec2020, but nothing to run to the hospital to the doctor for. Clarifies this occured after she received the vaccine. The outcome of the event allergies, mild eczema flare ups, itchiness and sores were unknown. The outcome of rash at site of injection was recovered on 27Dec2020. The outcome of other events was recovered in Dec2020. The causality between Pfizer COVID vaccine with some swelling of arm, rash developed 5cm x 4cm at injection site, chills and shivers, bronchospasm cough was related (Source of assessment: Primary Source Reporter, Method of assessment: Global Introspection). Information on the lot/batch number has been requested.

generally not feeling well; a low grade fever; chills; freezing; couldn't get warm; tired and run down; sleepy; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number EK5730), via an unspecified route of administration on 16Dec2020 08:40 AM at right deltoid, at single dose for covid-19 immunization. Medical history included sleep disorder. Concomitant medication included alprazolam prn (as needed) for sleep, HCTZ; losartan; metoprolol; montelukast sodium (SINGULAIR), levocetirizine dihydrochloride (XYZAL). On 18Dec2020 the patient had temperature of 98.8 which is low grade fever for her because she runs low. On 18Dec2020, she experienced a low grade fever, chills and was freezing. On 18Dec2020 she had chills and couldn't get warm. She had three layers on and a heating vest. It passed and she was doing fine. Those symptoms passed, but reappeared on 26Dec2020, last Saturday. Since then, she mentioned generally not feeling well, in addition to being freezing cold and experiencing chills every day. She had been monitoring her temperatures, and had no fever. Since 26Dec2020, she had chills, couldn't get warm, and no fever. She was tired and run down. She was sleepy and usually she was very energetic. The patient asked if have heard of such experience in other people. Seriousness Criteria was reported as it was not disabling, but annoying. It was unusual. She had on a thermal shirt that she would wear for skiing and that is not normal. Then on the 26Dec2020 the chills started back again. She felt kind of tired. She didn't feel sick, but not up to snuff. No AE required emergency room/physician office. The outcome of the event fever was recovered on 19Dec2020. The outcome of the events freezing; sleepy; tired and run down was unknown. The outcome of the other events was not recovered. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.

Felt mildly fluish by end of working shift (1130 pm), arm became more sore, unable to lay on it in bed. Woke up in middle of night with body aches , chills and headache. By 10 am felt increase in flu like symptoms, mild nausea, swollen glands, mouth cold sore and red hot face. Temp was 101.2. All joints hurt, general malaise.

On day 1 after the vaccine the employee began having muscle aches and sore joints. By day 4 she felt like she had an improvement in symptoms. On day 6 the same symptoms reappeared and the employee was tested for COVID (negative PCR). She reports that all of her joints in bilateral upper and lower extremities are extremely sore, she noted that "even her toes were painful". She is unable to take NSAIDS because of a history of anaphylactic reaction to Motrin in the past.

Progress Notes APRN (Nurse Practitioner) ? ? Nurse Practitioner Cosign Needed Expand All Collapse All COVID VACCINE CLINIC 1/6/2021   Date: 1/6/2021 MRN: 3274958   Subjective Patient is a 60 y.o. female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination.   She denied any history of previous adverse reactions to vaccines.   She was given the Pfizer vaccination in the right deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience dizziness and flushing. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling.   This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress with stridor, wheezing, dyspnea, increased work of breathing, persistent cough and cyanosis, skin changes, tongue swelling and vomiting.   Pt reports she saw an allergist this am for runny nose, SOB, and sneezing. He determined her symptoms was a neurological response. Previous COVID infection November 30, 2020   PREVIOUS REACTION: Pt reports first Pfzier covid shot she had symptoms of Chills, HA, nausea and fever of 102 that occurred 12 hours afterwards. She states her symptoms lasted 6-8 hours.     ALLERGY REVIEW OF SYSTEMS: Patient complains of dizziness       Objective   Vitals Vitals:   01/06/21 1235 BP: (!) 152/82 Pulse: 57 Temp: 99.2 °F (37.3 °C) SpO2: 100% BS 94 at 12:38   Physical Exam Vitals signs and nursing note reviewed. HENT: Head: Normocephalic. Left Ear: External ear normal. Nose: Nose normal. Mouth/Throat: Mouth: Mucous membranes are dry. Eyes: Pupils: Pupils are equal, round, and reactive to light. Neck: Musculoskeletal: Normal range of motion. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds. Abdominal: General: Abdomen is flat. Skin: General: Skin is warm and dry. Capillary Refill: Capillary refill takes less than 2 seconds. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal.       Assessment/Plan Treatment included: no therapy. Follow up response to treatment: no side effects. Patient discharge: Stable to go home and follow up with PCP.     Pt was observed and given water and food (peanut butter). Felt better within a few minutes. She was released to go home 12:55pm     APRN Electronically Signed 1/6/2021 12:45 PM    

dizzy; fever; elevated blood pressure; flushed feeling day of vaccine. The next day she continued to feel flushed; This is a spontaneous report from a contactable pharmacist. This pharmacist reported for a 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular route on 29Dec2020 15:00 at single dose for COVID-19 immunization. Medical history included COVID-19, hypertension and depression. Concomitant medications included vitamins received within 2 weeks of vaccination. The patient previously took duloxetine and experienced allergies. Facility that the most recent COVID-19 vaccine was administered in Workplace clinic. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 29Dec2020, the patient was dizzy, had fever, elevated blood pressure, and flushed feeling day of vaccine. The next day she continued to feel flushed that moved through her face and down her neck. It felt like she was on fire. The adverse events resulted in the following: Emergency room/department or urgent care. Outcome of the event feel flushed was recovered on 30Dec2020, outcome of other events was recovered in Dec2020. Treatment received for the adverse events included IV fluids, prednisone, diphenhydramine hydrochloride (BENADRYL). Events were reported as non-serious. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the events dizzy, fever, elevated blood pressure and flushed feeing cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

30-40 min felt flush skin on body face bright red. Numbness tingling in hands and feet. Took some advil. Over next two days on and off hot flashes tingling numbness on hands and feet. Very cold feet couldn't get warmed up till wrapped up on heating pad. Ño fever but felt chills. Sore arm site of injection.

Employee with low grade fever, chills and shaking starting at 2am. Tmax at 5:30 am of 101.2. Self medicated with Motrin with some improvement of symptoms.

Approximately 20 minutes post injection patient felt tingling/numbness in the left pinkie finger, migrated to right pinkie finger with one hours. Acetaminophen

Facial flushing, different sensation to head and ears, anxiety, unable to think. Pt. evaluated by MD, Benadryl 50mg IM administered with 1 hour in clinic observation. Pt. with improved breathing and relaxation, vitals stable.

Pfizer-BioNTech COVID-19 Vaccine Patient received Pfizer Covid-19 vaccine at 1043. Patient complained of tingling throat, no swelling noted. Patient alert, oriented and talking/answering questions appropriately. Voice noted to become hoarse with continued conversation. EMS alerted and took over care at 1107.

arm was sore; she has like underneath her neck, underneath her armpits, underneath her breast, on her stomach; inherited some type of reaction like a rash, its itchy; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EJ1685, Expiry Date: Mar2021, via an unspecified route of administration on left arm from 29Dec2020 to 29Dec2020 at SINGLE DOSE for COVID-19 immunization. Medical history included asthma, Hypertension (verbatim: Blood Pressure High), thyroid disorder (verbatim: Thyroid), cholesterol. The patient's concomitant medications were not reported. The patient stated she got her vaccination on 29Dec2020, that's Tuesday and her arm was sore the next day (30Dec2020) but she have inherited some type of reaction like a rash, its itchy, her hands are itching like crazy, she has like underneath her neck, underneath her armpits, underneath her breast, on her stomach that's not so itchy it's the hands that's itchy. The patient was asking what should she do. The outcome of the events was unknown. When asked for treatment for the events, the patient stated, "I was doing some, I take an Aleve, Aspirin and then I was taking some Benadryl capsule for allergy."

Chills, extreme weakness, and excruciating bone and muscle pain, diarrhea lasting 48 hours. Improved with Meloxicam. The keratitis flared up. Developed keratitis after the first dose on 12/17/2020. Lot EK5730. The keratitis presented with dry eyes, photophobia and reduced reading ability. I am treated with steroid drops and artificial tears.

HEADACHE (MIGRAINE) 8/10 . PATEINT REFUSED EMERGENCY SERVICES AND/OR CALL MD B/P 141/94 PR 64 @11:35 PM B/P 185/98 PR 60 @11:45 NO N/V NO CHEAT PAIN

1/1/2021: soreness at site 01/08/2021: headache,malaise 01/09/2021: redness & inflammation, hot to touch, swelling 3" x 3", small raised blisters. 01/11/2021: symptoms are subsiding; pink, warm to touch, swelling 2" x 2", blisters fading

COVID vaccine #2 given Thursday January7th 12:30. Body aches and chills started Friday January 8th approx. 1700. Worsening symptoms through the night. Fever and slight cough on Saturday morning with body aches, joint pain and chills.

Have very bad body aches and hot and cold sweats . I have been taking ibuprofen 2 times and symptoms get better.

Looked like an encephalopathy; Face was all swollen; Head swelled; Glands swelled; Fatigue; Headache/ So much pain in my head; Couldn't talk; Complete brain fog; nausea; This is a spontaneous report from a contactable nurse. This 60-year-old female nurse (Patient) reported that received bnt162b2 (BNT162B2, Pfizer COVID-19 vaccine), via an unspecified route of administration on 30Dec2020 at single dose for covid-19 immunisation. Medical history included Atrial fibrillation, Chronic Lyme, Lupus and Autoimmune. Concomitant medications included Metoprolol at 12.5 mg for Atrial fibrillation and acetylsalicylic acid (BABY ASPIRIN). No diabetes, no hypertension. None of the usual common diseases. Registered Nurse stated, "I received vaccine this past Wednesday. I was just talking to a couple of my colleagues and honestly I received the vac. at work. I did not really read through the paperwork and was 'weird' sharing reactions to the vaccine which for me was pretty bad reaction and thought like I need to go through your paperwork and report it. So I thought I should call and just give some information. The usual fatigue which I go to after being normal, my arm was not sore. However, as the week progressed into Friday I had a constant headache but it was manageable and then by Friday night my glands swelled, my nerves behind my ears, my neck and I was extremely fatigued, bad headache and went to bed and I had not gone out and finally I got out today I spoke with my Physician yesterday. What happened it looked like an encephalopathy but my head swelled, my face was all swollen, complete brain fog, fatigue and I couldn't talk. I was in so much pain in my head resulting in (incomplete sentence)." Lab work included the only thing is the PCR swabbing. No blood test. Registered Nurse further stated, "I don't know if that is important. But I will tell you and if it is you can send me the questions. I do have a history of Autoimmune. So my Physician thought that this was just like an enhancement of like my bodies reaction I have Chronic Lyme and I have lupus like my ANA has always been stressful. But we think that it is a family thing. No treatment for the Lyme. I did a lot of antibiotic and a lot of naturopathic stuff but that is in the past. But anyhow for anything else what I did was when I got the injection they said try and just take Tylenol not Ibuprofen but there was no way I was going to make it through with just that . So I took Ibuprofen. I called my Physician yesterday morning because I was not sure about what was is happening and I thought it might be secondary sinus infection or something else going on and it reassured me that it is definitely due to the vaccine. He said it is just your body's reaction, take the Ibuprofen, hydrate. Had me take what I had in my house Tigan for nausea. So I was extremely nauseous from the severity of the headache." Registered Nurse stated, "I just wanted to let you know what happened and the intensity of what it was because normally I would expect a headache. But this was a 'go dated'. Registered Nurse stated, "I guess the only question that I have is so do my work has this question and I was going to call my doctor tomorrow may be might know it better. I know that I have to take the second dose. But I understand the second round can be worse than the first. Is there anything that they are recommending that I can do may be prior to ease the reaction?" The outcome of the events was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: The reported clinical manifestations including swelling face and head swelled, which was suspected as encephalopathy by the reporting nurse, was probably related to the bnt162b2 (BNT162B2, Pfizer COVID-19 vaccine), due to temporal relationship. The subject's underlying Chronic Lyme, Lupus and Autoimmune were likely the risk factors to the onset of the events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory authorities, Ethics committees and Investigators, as appropriate.

Pressure in my head behind my ears. Clear drainage from my nose. Feeling shaky has been going on for past 15 days. Due for second dose afraid to take it.

She experienced head ache, neck pain, sinus pain, weakness, aches, very short of breath on exertion and when wearing a mask. Aching in left arm, in chest and in right arm pit. Very dry eyes and bloodshot. Sweating and very warm. Temperature 1-11-21 96.2°F

four hours after receiving vaccine, I experienced diarrhea, then fever. Weakness, fatigue and increased fever continued thru the night and not able to sleep, very restless. The next morning after I had more weakness and major flair up with my MS, where I fell several times and was not able to get myself off the floor. Each time I fell it too approximately 20 minutes for me to get either in bed or a chair. Still had fever of a 100-101 through out the day, took ibuprofen to help, which it did for a short time but then fever was back. About 7pm I took some Benadryl and was finally able to fall asleep. The next morning, no fever but very weak. Went to health club to help with my legs. This day was ok, weak but improved. No falls

Arm pain; Full body aches; Headaches; Frequent bathroom use (not diarrhea more of a mix); Mild wheezing; Nausea; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 05Jan2021 at a single dose for COVID-19 immunization. Medical history included ongoing asthma (asthmatic) which had been under control for years. The patient's concomitant medications were not reported. In Jan2021, the patient had arm pain; full body aches; headaches; had frequent bathroom use (not diarrhea "more of a mix"); mild wheezing; and nausea. The patient had received paracetamol (TYLENOL) as treatment for the arm pain. The outcome of the events, 'arm pain', 'full body aches', 'headaches', 'frequent bathroom use', 'mild wheezing' and 'nausea', was unknown. Information on the lot/batch number has been requested.

Dizzy Clammy Heavy legs Frequent PVC on monitor Irregular heartbeats Headache Tightness in throat and chest

developed more severe arm pain, headache, rigors, muscle aches- lasted approx 3 -4 hour- took tylenol, used heating pad

the patient began to experience dizziness and flushing; the patient began to experience dizziness and flushing; This is a spontaneous report from a non-contactable other healthcare professional. A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK9231), via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The female patient who was seen at (Clinic name) today on 06Jan2021 for her second dose of the COVID 19 vaccination. During her 15 minute waiting period after the injection, the patient began to experience dizziness and flushing on 06Jan2021. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness. The outcome of the events was unknown. This case was reported as non-serious. No follow-up attempts are possible. No further information is expected.

At 4hrs post vaccination experienced extreme muscular pain between shoulder blades. The following week, as far as I can recall, I began to have tingling from the right shoulder blade down to my hand. I thought I may have a pinched nerve and went to the walk in clinic to be seen by the nurse practitioner that is in the same office as my primary. She examined me and thought it sounded like a pinched nerve and said I was swollen in the area of complaint. Cervical and thoracic x rays were taken (normal) and was told to take Flexeril and steroids. Pain was getting worse and primary told me to begin taking Meloxicam and have physical therapy. I have been doing both beginning 1-11-2021. Pain continues with no improvement. Do not know if my symptoms are caused from the Covid shot, but just seemed to me that it was quite a coincidence that muscle pain began on the same day as receiving the shot.

Her arm was a little sore; The soreness at the injection site lasted 2 days; This is a spontaneous report from a contactable consumer reporting for herself. A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration (arm left) on 08Dec2020 (lot unknown) at SINGLE DOSE; and second dose via an unspecified route of administration on 06Jan2021 at SINGLE DOSE (lot number EJ1685) for COVID-19 immunization. The patient medical history was not reported. The patient was taking unspecified concomitant medications (same medications that she usually takes and has not started anything new). Patient reported that she was fine after the first shot. Her arm was a little sore on Dec2020 and that was it. The soreness at the injection site lasted 2 days and then recovered completely. She has no breathing difficulties or anything similar. Outcome of the event "Her arm was a little sore" was unknown while recovered for " The soreness at the injection site lasted 2 days" on Dec2020.

Pfizer-BioNTech COVID-19 vaccine EUA - Client reports "after 45 minutes post injection, started having mild itching in my trunk, arms and left Hand. itching increased so took Benadryl 50 mg PO, stayed for 15 minutes then left work to go home. Once home itching increased, eyes started swelling and started losing my voice. Husband took me to the ER at Hospital, arrived approx. 6.10 pm. Treated with Benadryl, Solu medrol and Pepcid, all thru IV. Condition improved and client sent home with script for Pepcid, Medrol dose pack and Atarax.

Ringing in ears; Triggered to migraine; Cannot hear, Sounded like everything was muffled; Headache; This is a spontaneous report from a contactable Nurse. A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EK9231), via an unspecified route of administration on 04Jan2021 14:56 at SINGLE DOSE for COVID-19 immunisation. Medical history included hypertension, previously had an allergic reaction to just one antibiotic. Concomitant medication included nifedipine, carvedilol. Consumer stated, "About 15 minutes into after getting the injection, I was sitting to the site they asked me to stay longer because I previously had an allergic reaction to just one antibiotic (Unspecified Medication).So that was within the 15 minute mark I started getting ringing in my ears and at the 20 mark I had migraine. I had them since I was about 9, they were diagnosed, it triggered a migraine. Although the ringing had gotten better in the last year but it is really bad in the right and it is now causing me (incomplete sentence)." Consumer stated, "I am probably say like I am yelling at you. I cannot hear and my son keeps telling me mom you are yelling. I did not see that I am 'ringing to your sheath' ringing in the ear, the headache. I just see my headache is better today. I had a little bit of it but nothing you know Excedrin or something would take care of not enough for me to go take that but it is the ringing and I cannot hear out of that ear. I put my phone up and ringed up. Consumer stated, "Recently my mom had COVID (further not clarified), I barely heard it. On the 23rd of Dec and I keep in contact with my family,they are 13 of us and I picked up the phone and instinctively put it to my right ear, I could not hear and I kept looking at the phone and I thought wait a minute and I put it to my left seems to be okay. It is the right I cannot hear." Consumer further added, "I am a Nurse so you expect this, that is why I waited this long because I got the injection at like 3 O'clock yesterday and I waited even longer thinking maybe it will just go away and So I know you guys want to know everything that is going on. So I said wise better to call." Date of vaccination: Consumer stated, "04Jan2021 (Clarified as 04Jan2021) and the time was 2:56 PM." Consumer further added, "It is the only thing I could think of. It is the only thing that I could think of that I did differently out of my daily habits to go get this injection. I would say within 15 minutes it just started turning my head and I was like wait a minute I am having ringing and then they had music playing above our head, it sounded like everything was muffled then I turn my head to the right I could hear better and they kept turning my head and one of the administrators at the table started looking at me so I get up and I said you know what I am having ringing in my ear so they had me seated there a bit longer." Dose and route of administration: Consumer stated, "I think she pulled up one cc that I saw and I got it in my left deltoid." Treatment: Consumer stated, "No." Causality: Consumer stated, "I would have to say because it started like say in the 15 minute mark and then the headache came in about 20 minute mark." The outcome of the event Headache was resolved while the outcome of the other events was unknown.

The day after my arm was very soar for at least 48 hours, no fever just laying around. I had low energy for about three weeks and I'm just now feeling better. Around the 26th my lymph nodes swelled up (three of them) . I called my PCP, he told me to take Tylenol is painful and to put warm compress if they were uncomfortable. They are still there, they don't hurt or painful.

Patient received her first dose of COVID-19 vaccine at 9:27 am. Around 9:40, the patient complained of head tingling and body itchiness.

Received 2nd dose Pfizer lot EL0142 in right arm on 1-13-2021. Employee is experiencing body aches and cramping all over.

flushing/ felt feverish and it was not a rash, she just felt flushed; hot/ felt really hot; soreness in the arm; little headache; experiencing tingling in hands and feet (mostly in feet); experiencing tingling in hands and feet (mostly in feet) and they feel cold; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) via unspecified route on left upper arm at single dose for COVID-19 immunization on 05Jan2021, 12:30pm at 60-year-old. Medical history included: ongoing diabetes type 2; ongoing gout; went through menopause 10 years ago (2011). She had pulmonary emboli 3 years ago (2018) and had some scar tissue but not on oxygen though she did get short of breath. No relevant family medical history. The only reactions she has ever had was 15 years ago (2006), she had a CAT scan and experienced hives the next day due to the contrast medium. She thought it had since been changed as she had had it twice since then and was given diphenhydramine hydrochloride (BENADRYL) but experienced nothing again. Concomitant medication included: ongoing dulaglutide (TRULICITY) for diabetes type 2 and ongoing oral medication (unspecified) for gout. No additional vaccines administered on same date of BNT162B2. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685) single dose for COVID-19 immunization on 19Dec2020 around 12pm and 2 pm. The patient previously got the flu shot (unspecified) every year, 3 years ago (in 2018) she got the shingles vaccine and had also had the pneumonia vaccine (in 2018) but never experienced anything from those products. The patient previously took allopurinol for pulmonary emboli and had had no reoccurrence. She took warfarin for short of breath. The patient had flushing on 05Jan2021, she was hot and turned red like a cherry. She had an episode where she felt really hot like hot flashes or almost like she was flushed. Her face was red as beet and her arm and hands were red, this lasted about an hour and she took ibuprofen (ADVIL) for it. It seemed to be resolved but had come and gone through the night. She was up checking on her puppies so that was how she noticed. She had taken her temperature and it had been 97.6-98.1 which was normal for her, but she was still getting the hot flashes and flushing. She felt feverish and it was not a rash, she just felt flushed. After the vaccine, the patient reported soreness in the arm on 05Jan2021. The patient was experiencing tingling in hands and feet (mostly in feet) on 05Jan2021 and they feel cold. Tingling started about 45 minutes to an hour after the dose. The first time lasted 3-4 hours and then went away. It came back in the middle of the night for a couple hours and then again this morning. This morning it had been going on for 2-3 hours and was still going on right now; it started about 6:30am-7am. They feel cold but her feet were really cold. She had socks and slippers on, but they didn't seem to get warm. She went on to explain that her hands and feet have profusion. During this she had checked her pulse ox (oximetry) related to her cold hands and it had been 92-95% (on unknown date) which was good. She had also checked her pedal pulses even though they were cold, and a little they were a little on white side, they blanch although might be a little slow but nothing alarming. The patient had a little headache on 05Jan2021. Other than that, the patient felt fine. No emergency room or physician office visited. No relevant tests. Action taken for BNT162B2 was not applicable. Outcome of the events flushing, hot/ felt really hot, soreness in the arm, tingling in hands and feet (mostly in feet) and they feel cold was not resolved; outcome of the other events was unknown. Causality assessment between the Pfizer product (BNT162B2) and the events (tingling, flushing, soreness in the arm) per the reporter was reported as related.

1/13/21 had pain in R arm and employee woke up 1/14 with cramping, chest pain and feeling of heaviness from belly button down to the legs. Advised to go to the EC for evaluation. Update 1/15: Seen in ED and had EKG with inverted T wave. Still has heaviness in legs. Will get a referral to cardiology after speaking with PCP.

Employee reported chills, muscle aches, headache, pain at injection site, fatigue, nausea, pruritus, and pressure on her upper back. She reported feeling anxious when she laid down. She went to see her doctor last week and was treated with benadryl.

I got the vaccine in the AM and I was fine all day just a little itchy in the morning. Around 2AM in the morning I had high fever, chills, and a very bad headache, and shooting pain like a shock in legs and arms (I had the same when had covid around 04/2020 and was out of work until June 2020 - I developed double pneumonia). It lasted until 11AM the next day. Got a covid test around noon and it was negative and on the 25th I started feeling better. Got second dose on 01/13/2021 had the same symptoms but not as severe.

Right after shot body felt on fire, within 5 minutes tongue start swelling, face, neck and injection site red, BP went to 170/120, very fatigued and throat closing.

left neck moderate to severe pain; pain started radiating down her left arm and down left leg; weakening her joints on those extremities/ shoulder pain; This is a spontaneous report from a contactable other healthcare professional reporting for herself. A 60-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number: EK5730, expiry date: unknown), via an unspecified route of administration, on 16Dec220, at a single dose on arm right for COVID-19 immunization. Medical history included diabetes mellitus 2, hypertension (HTN), migraines, back pains, hypothyroidism, and allergies to latex and kiwi. The patient received the vaccine at a military base. She did not receive other vaccines in four weeks. The patient was not pregnant at the time of vaccination. She had no COVID prior vaccination and was not tested for COVID post vaccination. Concomitant medications included unspecified medications; she received other medications in two weeks. The patient previously took gabapentin and topiramate (TOPAMAX), in which she experienced allergies. On the second day after receiving the vaccine, 18Dec2020 04:00 AM, the patient started feeling left neck moderate to severe pain, and the pain started radiating down her left arm and down left leg, weakening her joints on those extremities. This continued severely for 3 days. At this time, she continued to feel mild left neck, shoulder and arm pain intermittently. She could not report this immediately due to not having her vaccine documents which she forgot at her workplace as she proceeded to vacation. She had paused in getting the second dose that was due on 07Jan2021, waiting to hear from Pfizer. The patient received NSAIDS and Muscle relaxant medications as treatment for the reported adverse events. Outcome of the events was recovering.

reported "weird" sensation in her body and "like a pulsing in my chest". 1337 - Patient reports weakness,

I lost my voice, my face tingled, my eyes Got puffy, itchy, and watery, extreme fatigue, and minor difficulty breathing. I had an increased you can buildup up in my throat and nose, with coughing. I took two Benadryl; about 45 minutes later my breathing improved. I took the Benadryl at 8:15 AM. It?s now 2:25 PM and my eyes are getting itchy and starting to feel puffy again. My voice is still very hoarse.

Received shot at 10:53pm; I did take all of my medications and supplements listed except for the Thyroid medicine before going to before at midnight; very restless night of sleep. The pain in my arm woke me up. I never felt like I fell asleep. I woke up at 530am and took my Thyroid medicine and went back to bed until 6:30am. Felt fine until about 830am. I noticed I was starting to feel lightheaded and had this pressure on my head. I went back to bed and tried to fall asleep but really never did. I noticed that I would lose track of my train of thought often. Got up at 11am and took a shower and still just didn't feel like I had any motivation to do anything, so rested again. I then noticed my face, ear lopes and cheeks felt a little numb. I would pinch them and I noticed they were numb. Also, there was still pressure on the back of my head and on the bridge of my nose. Still light headed. I layed in bed until about 3pm when I did notice the numbness going away and the pressure on the back of my head and on the bridge of my nose getting a little better. Also, no appetite.

Initial symtom of warm flush (head to toe), followed by added symtoms over course of next 5-10 min: light headed, dizziness, pale, tachycardia, scratchy throat, heaviness in chest, tightness in throat, spike in blood pressure (initial 144/88, 168/96, 152/87, 146/84-final). Monitored symptoms 45 min to one hour. Temp 97.3. Symtoms lasted approx one hour, then began improving, with exception of light headedness and general malaise and fatigue for 4 hrs. Additional event at approx 10 hours post vaccine: excruciating upper arm pain (left shoulder to elbow), felt "down to the bone". Unable to move arm and very painful to touch. Took 600 mg ibuprofen. Severe pain lasted approximately 3-4 hours (unable to sleep). Then became moderate soreness at injection site x 8 hrs. Mild soreness x 12 hrs, no pain 36 hrs after vaccine. Continued fatigue and malaise for 3-4 days after vaccine.

Within 15 mins of receiving the vaccine I had slight tingling in my R cheek. Within 2 hrs of the vaccine I had R facial numbness from maxillary to ear and lower jaw. Within 6 1/2 hrs from the vaccine, I had R lateral calf numbness. Within 8 hrs of the vaccine, I had R hand and arm numbness, R side of mouth and tip of tongue numb, R orbital swelling, scratchy R eye, maxillary tenderness. Advil was taken 9 1/2 hrs after the vaccine. Symptoms improved by next am, and gone by 24 hrs post vaccine.

Left upper eyelid spasming several times an hour day and night for about 10 days, then starting to lessen to every couple of hours day and night

SORE ARM 8 HRS POST VACCINE. THEN, HEADACHES AND MALAISE. MINOR BODY ACHES UPON AWAKENING THE NEXT MORNING. ALL LASTED UNTIL ABOUT 28 HRS POST VACCINE.

limping one side of foot; wanted to pass out; numbness to right side of face; every muscle in her body hurts; stomach is cramping; This is a spontaneous report from a contactable consumer. A 60-years-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140) , via an unspecified route of administration on 04Jan2021 at the first single dose at Arm Left for covid-19 immunisation . Medical history reported as none. There were no concomitant medications. The patient experienced wanted to pass out, numbness to right side of face, every muscle in her body hurts, stomach is cramping on 08Jan2021, limping one side of foot on 11Jan2021. The outcome of event wanted to pass out was unknown; outcome of event numbness to right side of face, stomach is cramping, limping one side of foot was not recovered; outcome of event every muscle in her body hurts was recovering;

Approximately 20 minute after vaccine administration, returned to unit and became lightheaded and foggy. Unable to fully concentrate on tasks. Flushed in face and unsteady lasting approximately 1 hour. Developed headache lasting remainder of shift. Developed body aches/chills in evening

Feeling sick/Not feeling well; Exhaustion; Dizziness; Shakiness; Sore throat; Sleeping nonstop; Headache; Vomiting; Diarrhea; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received BNT162B2 (batch/lot number: EK5730), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient worked at a hospital doctor's office. On 22Dec2020, the next day of vaccination, patient immediately for two days had "immense" (not clarified) headache and then had two days of vomiting and diarrhea. And she had been sick "ever felt" (not clarified) on an unspecified date. She had extreme exhaustion. She had been tested for everything from "manual" to mild "disease" (not clarified). She had extreme exhaustion, dizziness, shakiness, sore throat and Monday would be three weeks that she had been feeling like this. She had never been sick like that she felt like this way. She was supposed to get the second vaccine the day after the time of the report yeah so any way. They wouldn't give her because she was not feeling well but she wished just going to hold off and might be try it all over again in couple of weeks when she felt better but she really felt not well since had gotten this vaccine. She had never felt like this before in her life had ever felt this way all ever. She had taken an over the counter medication cold and flu medication (further clarified CareOne (batch/lot number: OCE2948, expiry date: Nov2021)), and ibuprofen (ADVIL, batch/lot number: R85569, expiry date: Mar2023) and she had been doing lot of sleeping. She had been sleeping nonstop. The patient underwent lab tests and procedures which included EKG and all kind of blood work with unknown results. Outcome of the events was unknown. Causality was reported as yes by the consumer.

Within approximately 2 hours of receiving vaccine, patient experienced slurred speech, dilated pupils, and was slow to respond to questions. Patient felt "foggy," similar to waking up from anesthesia.

began having tingling to face & tongue @ approx 0915 progressed to tongue and mouth swelling and rash to face

fever (100,4, 101 and 100); I was a little ache like a flu; I was a little ache like a flu; Felt really hot in my face; I just kind of felt little nauseous; Little bit of chills; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunization. The patient medical history included ongoing hypertension. Concomitant medication included amlodipine besilate at 5 mg once a day for hypertension, acetylsalicylic acid (BABY ASPIRIN) at 81 mg once a day, vitamins and metoprolol succinate at 50 mg twice a day for hypertension. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. On Jan2021, the patient reported that: " I was running a fever like above 100.4, I was a little ache like a flu" and " I woke up and I just felt really hot in my face, I just kind of felt little nauseous and a little bit of chills and I took my temperature and it was like a 100, so I went to work and I did take a TYLENOL, 2 extra strength TYLENOL around 9:00 and I felt much better and now I am feeling like a fever is coming back so I took my temperature and I was getting like chills again and I took my temperature and it is 101". The patient outcome of the events was unknown.

Day 1-3: had headache, generalized itching and swelling of the right side of the face and eyelid. Took Tylenol Day 6: diagnosed with Bells Palsy by PCP 1/8: went to doctors for evaluation by PCP of symptoms currently patient still experiencing swelling of the right side of face and slight itching

Dizziness, Nausea, clammy, shaky, trouble swallowing, throat closing, pulse racing . Treated at WS GSH ED Was given Benadryl, Prednisone and Pepcid orally Was discharged after 4 hours

Within 5 minutes of getting injected, felt heat over entire body, from top of head to toes, heart rate increased. Nurses came over and took VS. BP 180/100, P128, Throat scratchy and hard to swallow. Monitored continuously and had epinephrine ready but didn't inject as about 10 minutes later symptoms started to subside. Stayed in hospital for longer period (unsure of exact time) and then went home. Over the next 2 days, felt listless, weak and no appetite.

Within an hour of the vaccine face was hot and muscle in face were painful in the jaws, sinuses up in nose felt weird and dry like menthol. Put ice on face. Took Tramadol. Having fatigue. Next day felt better, then started having brain fog difficulty remembering, vision is blurry, no energy and feel exhausted.

received 2nd dose at 7pm 1/18/21. woke up tuesday with sore arm went to work and while working afternoon progressed to chills and total body aches. temp 101 through evening up and down after motrin to next day Wednesday. wednesday had some chills but during night into Thursday had joint pain no fever. woken up thursday with joint pain and headache no fever.

taking new meds for allergic; red spots on roof of mouth; bumps on roof of mouth; rash around the corners of my mouth; sore arm; nausea; headache; This is a spontaneous report from a contactable consumer. This consumer reported for that the 60-year-old female patient who received first dose of bnt162b2 (Pfizer Pfizerbiontech covide-19 Vaccine EUA), via an unspecified route of administration on 03Jan2021 10:00 AM on Left arm at single dose for covid-19 immunisation. She is not pregnant. Medical history included Known allergies: Penicillin sulfa. No other vaccine in four weeks. Concomitant medications included in two weeks: escitalopram oxalate (LEXAPRO), valaciclovir hydrochloride (VALTREX). The patient experienced Day 1 sore arm, nausea, headache from 05Jan2021 12:00AM, Day 2 nausea from 06Jan2021, Day 3 rash around the corners of my mouth from 07Jan2021, Day 4 bumps on roof of mouth from 08Jan2021, Day 5 red spots on roof of mouth from 09Jan2021, Day 6 Continued red spots went to Doctor, Day 7 taking new meds for allergic reaction from 11Jan2021, Day 8 headache mouth improving. AE resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovering. Treatment was received included Doxycycline. No covid prior vaccination. No covid tested post vaccination. No follow-up attempts are possible; information about batch/lot number cannot be obtained.

INJECTION 1===back ache, heat from waist down to top of knees, no fever INJECTION 2===rash on top of both legs- no fever

Patient had stated she felt well. 1-2 minutes later she c/o feeling woozy and was uncertain if her right hand was pale. + tingling. Brought to be evaluated by EMT.

Sore arm, severe headache- severe body aches, chills, low grade fever. Symptoms started 10 hrs after vaccination and lasted approximately 36 hours.

12 hours after injection uncontrollable shaking with chills, severe headache and body aches. Hours later turned into sweating/heat. Mild upset stomach throughout. Soreness/brusing at injection site. After 18 hours headache persisted with mild body aches and upset stomach. Still soreness /brusing at injection site. 24 hours after injection very mild backache. No headache. Soreness at injection site. No other issues.

Chills (freezing), aches and pain all over, headache, felt feverish with no fever, painful arm at site of injection with swelling- took total of 4 tylenol over a course of 20 hours- symptoms lasted about 20 hours- arm swelling and pain lasted about 3 days

Pain through whole body and tremoring; Pain through whole body and tremoring/ whole body was sore; Things started looking funny/ Funny feeling in her ears; Deaf and couldn't hear; Leg cramps in both legs and toes curled out/ muscle spasming; Dizzy; nauseous; Threw up twice; Bruise at injection site; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EL3246) via an unspecified route of administration on the arm left on 05Jan2021 around 12:00 PM at single dose for COVID-19 immunization. The patient used to get legs cramps when she was pregnant with her twins, but it was only one leg. The patient stated she delivered six children, was in car accidents, and had surgeries. And the patient stated the pain from the COVID-19 Vaccine was beyond any other pain she has experienced. The patient needed glasses to read patient card. And stated her eyesight was going. The patient was pretty healthy. There were no concomitant medications. The patient had no prior vaccinations within 4 weeks. And the patient did not receive additional vaccines on same date that administered BNT162B2. The patient experienced deaf and couldn't hear on 06Jan2021 09:00, leg cramps in both legs and toes curled out on 05Jan2021 19:00, dizzy on 05Jan2021, nauseous on 05Jan2021, threw up twice on 05Jan2021, things started looking funny on 06Jan2021 09:00, pain through whole body and tremoring on 06Jan2021 10:00, bruise at injection site on Jan2021. All the events (except for event bruise at injection site) were reported as seriousness as life threatening. Clinical course: the patient worked nightshift. Laid down that afternoon to take a nap and got up around 10:00. Around 05Jan2021 19:00 PM had sever leg cramps in both legs where her toes were curled out. Leg cramps after vaccine wouldn't go away and it was in both legs. Just wouldn't go away. Around 05Jan2021 21:00 PM it went away. The patient was dizzy, nauseous, and threw up twice on the night of 05Jan2021, and going into 06Jan2021. The patient went to the couch in the hotel room and started going deaf. She couldn't hear anything on 06Jan2021 around 09: 00 AM. Things started looking funny on 06Jan2021 around 09: 00 AM. Woke up at 09:35. Hour after that there was pain through her whole body and everything was hurting at 10:00 AM on 06Jan2021. The patient was tremoring at 10:00 AM on 06Jan2021. Couldn't reach the phone to dial 9-11. Thought she was going to die. Last until about noon and then started to go away. Doesn't know if it is safe to take the second vaccine. Doesn't know if these are thing that should have happened to her. She started to get real concerned. Went into hotel room and started feeling dizzy again. Stopped haring things. Funny feeling in her ears. Was seeing things, got dizzy, and everything got dark. Everything lasted until 12:00 PM on 06Jan2021. Everything was good now. The patient had a bruise where injection was in Jan2021. Stated it was nothing compared to what she went through. Woke up around 10:00 AM. Then went back to sleep and got up around 18:00 PM. She felt fine. Her whole body was sore from the muscle spasming. The outcome of the event bruise at injection site was unknown, of the event leg cramps in both legs and toes curled out was recovered around 05Jan2021 21:00, the outcome of other remain events was recovered on 06Jan2021 12:00. The reporter considered (method of assessment: Global Introspection) that all the events were related to BNT162B2.; Sender's Comments: All the reported events were possibly related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship. However, it is worth noting that the 60-year-old female patient had car accidents history and had surgeries. All the events started when she worked nightshift, including leg cramps in both legs and toes curled out, nauseous, threw up twice, pain through whole body, tremoring and transient deafness. Patient did not get rest after vaccination may a risk factor to the onset of the events. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Temperature 101.7; Back pain/pain in her back; Right upper jaw pain that felt like sinus; Heart rate 130's; Oxygen Saturation dropping; Headache/head felt like it would explode; Ringing in the ears; Thighs are burning; calf pain/Calves were sore in back; Calves were sore in back and felt like DVT; Chest pressure; she sound like a hypochondriac; flu like symptoms; can barely walk; Nausea; Shivering; weak; felt miserable; dry hives; This is a spontaneous report from a contactable Nurse reporting for herself. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Batch/lot number: EL1283, Expiry Date: 30Nov2021, intramuscularly into right deltoid on 11Jan2021 07:15 at single dose at the hospital for Precaution as frontline healthcare worker. Medical history included Wolff-Parkinson-White (WPW) syndrome from 2000, heart surgery in the past on unknown date, had surgery that was in 2000. Years of chest pain and PVC after that; allergic to Sulfa with hives: One time she mixed it up with a medication of her sons and took it by mistake and did not realize it and she did not have any reaction, she has not had in years. It was an injection and she doesn't have the name, lot or expiration. Family medical history included Mother was diabetic and sister was prediabetic and was 61. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (Lot E49899) on 18Dec2020 at 10:30 am injected in Right Deltoid for COVID-19 immunisation and experienced shivering; same body aches, she took TYLENOL; had major headache all night long, all over her head; It was a pressure headache; Someone gave her MOTRIN and within 3 hours she was totally fine. The patient stated she received the Pfizer COVID vaccine second dose on 11Jan2021 and has had problems since then. She has been miserable, took paracetamol (TYLENOL), headache, have ringing the ears, head was exploding, back aches, calf pain, temperature at 8 am 101.7 and 101.7 at 10:40 on 12Jan2021, feeling very weak, nausea, dry hives, Right upper jaw pain that felt like sinus, all in Jan2021. Her heart rate was in the 130's at 3:30-4:00 on 12Jan2021 and now down to 115-108. Her Oxygen saturation has been 91-95 %. She just had a miserable night (Jan2021). She had this pressure in her chest. Her heart rate was 130 and O2 was 93%. Her O2 saturation last night (on 11Jan2021) was 91-94%, mostly about 93%. Chest Pressure began around 3am on 12Jan2021. She called healthcare provider and was waiting to get advice from them if she needs an EKG. She was still having a little bit of mild pressure. She noticed that her oxygenation was 93% when this was happening. It went up to 95% for a second last night. Her heart rate was now between 112-115. When she walked, it went to 125-130. It started around 3:30-4:00 this morning (on 12Jan2021) and was mildly improved. she was feeling the chest pressure back pain had lesson, but had pain in the upper jaw, flu like symptoms on 12Jan2021. she said she could not get out of the bed right. She did have a heart surgery in the past, her legs were burring, and week. she said after the first dose she did had a reaction but took MOTRIN and went to work the next day. The patient wanted to know about the heart rate being high and ringing in the ears. She wanted to know if it was supposed to drop your saturation and increase your heart rate. Is she just behaving like the norm or should her O2 be much higher. Her first shot was not as bad as this reaction. There was no prescriber. The temperature just began now as she just took it. Oxygen Saturation dropping began when she woke up in middle of night around 3:30- 4:00. She used her pulse oximeter and noticed it then. It was associated with her ears ringing and her head felt like it would explode at 3:30 on 12Jan2021. She felt better with headache but still had it. She was so weak on 12Jan2021, she did not want to go anywhere. Her oxygenation had worsened to 93% on average. She had a headache last time but did not have ringing in her ears. She woke up about 3:30 with it. The headache now was all over head from front to back and comes and goes. Last time she went to work after receiving the first one and today (on 12Jan2021), there was no way she could go to work. She took TYLENOL when she got home because she was shivering and took more at 3:30 because she felt miserable because of her chest. She took 1 gram. Her headache did not go away. She got to sleep after she took the TYLENOL. Her back and jaw was bothering her. It felt like the flu. She had upper jaw pain and pain in her back. She didn't have a good back and just aches. After the first one, it took 10 hours for the shivering to start. This time it was very similar. The shivering started about 10 hours later, at 9pm on 11Jan2021. Back pain starting at 05:00 on 12Jan2021 was stated as being sharp on right side scapula and feel like the flu. It is to the right of spinal vertebrae. She thought she would go to bed and lie down. She has had back pain before. The jaw pain started around 05:00 on 12Jan2021. She felt it in her cheek. It was a little bit better. Nausea started at 11:00 pm on 11Jan2021 and got worse at 03:30 when she got up to go to the bathroom around midnight. She felt like she could vomit and felt better, but she couldn't. Her thighs were burning at 03:30 on 12Jan2020. It was persistent weak and burning. She can barely walk. The areas that have hurt like when you get the flu, she was having now in the same places, so she thought it was from the shot. Calves were sore in back and felt like a DVT (Deep vein thrombosis), started at 03:30 of 12Jan2021 and was still sore. She said she sound like a hypochondriac. It was in back of calf towards knee. She did not think it was a blood clot. It was feeling better. It was still sore but nothing like it was at 03:30. It is just an odd pain. She did not want to leave the house and surprised that her oxygen saturation was low. She just wanted to go back to sleep for a bit. Oxygen Saturation dropping was reported as worsened. The outcome of events Chest pressure, Heart rate 130's, Headache/head felt like it would explode, Right upper jaw pain that felt like sinus, calf pain/Calves were sore in back and Calves were sore in back and felt like DVT was recovering. The outcome of events Oxygen Saturation dropping, Ringing in the ears, Shivering, Back pain/pain in her back, Nausea, and Thighs are burning was not recovered. The outcome of events Temperature 101.7, she sound like a hypochondriac, dry hives, flu like symptoms, weak, felt miserable and can barely walk was unknown. The reporter considered events Heart rate 130's, Temperature 101.7, Oxygen Saturation dropping, Right upper jaw pain that felt like sinus and Thighs are burning were related to BNT162B2. The reporter considered events Chest pressure, Heart rate 130's, Temperature 101.7, Oxygen Saturation dropping, Headache, Ringing in ears, Shivering, Back pain, Nausea, Thighs are burning, Right upper jaw pain that felt like sinus and Calves were sore in back and felt like DVT as serious due to Medically significant.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Left arm very painful, pain in my neck left side goes into my chest and back of head left side, dizziness, and horrible fatigue. Feeling out of it.

Syncope,dizziness, head spinning,weakness of arms slurred speech BP 195/105 PULSE 91 Repeat BP 167/92

The patient experienced syncope within 30 minutes after receiving the covid-19 vaccine. At 2:30pm, she felt dizziness, her head was spinning, weakness of the arms, and slurred speech. Her FS was at 108 (Normal), BP 195/105 (Extremely high), Pulse 91, O2 saturation was at 100%. At 2:48PM, her BP lowered to 167/92. At this time, she can smile, she can put her hands up, she can kick her feet and she can opened/closed her eyes. Due to her high BP, Doctor requested that the should go to the ER via the ambulance.

sore arm; This is a spontaneous report from a contactable nurse (patient). This 60-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 19Dec2020 for COVID-19 immunization. Medical history included asthma; hypertension; acid reflux; food allergies; known allergies to peanut, shell fish, IVP dye, penicillin and tree nuts. Patient also had known allergies to erythromycin and ceftriaxone (ROCEPHIN). Concomitant medication was not reported. There was no other vaccine in four weeks. On the first dose of 19Dec2020 just a sore arm (date unspecified). The outcome of event was unknown. Information on lot/batch no. has been requested.

C/o muscle aches, calf cramps, (B) feet numbness, cough, nausea, diarrhea, all began after #2 vaccine. No problems with #1 vaccine Tx antiemetic, H2 blocker, anti histamine, Tylenol push fluids

Fatigue but only in evening. Able to work. Irregular heart beat (not normal intermittent PVC) that caused chest discomfort. Nothing concerning, just more curious. With second vaccine, developed chills within one hour and went to bed. Upon awakening, had headache, nausea, chills, kidney area pain, chest discomfort from irregular heart beat. This resolved for about 18 hours, then started again and lasted for 1 week. Chest pain became sharp at times spreading to arm with mild shortness of breath. Having had a full heart workup last year, did not pursue tests. wanted to see if would pass on it's own. After one week, only have occasional chest discomfort. Arrhythmia has returned to baseline occasional PVC. No further chills, headache, nausea or other pains.

First vaccine small bruise at her left knee and extreme pain in her neck, shoulder and left arm and missed work. Second vaccine she has 4 bruises and clots on her inner leg from ankle to thigh. So painful she can't sleep and she is having a hard time walking. Her left shoulder is limited due to extreme pain. She sought care from her physician and he is sending her for scans that the facility is requiring a deposit.

There are two events I am reporting, one each from the first dose on 12/19/20, and the second dose on 1/9/21: Approximately 53 hours after Dose #1: Redness on hands and wrist, rash-like small dot appearance on hands and wrists, skin dryness and tightness of hands. I experienced no itching of hands or wrists. Approximately 53 hours after Dose #2: Small, painful red pustule-like occurrence on base of right thumb, with the appearance of a few small dots in it. I experienced no itching of thumb or hand. These events both occurred within the same timeframe following the vaccine doses. Following the first event I was seen in the ER. I checked out fine and they could not say exactly what this was. They said it did not appear to be an allergic reaction to the vaccine because it was not systemic and I had no other symptoms such as trouble breathing. They thought perhaps it was coincidental...I work in the hospital as a radiologic technologist where I hand-wash and hand-sanitize all day. Perhaps I just over-washed that day? However I've worked there for 17 years and never had this happen. The redness and rash dissipated by end of day. Following the second event I did not follow up with any medical provider. This pustule I got happened while I was at home, and otherwise I felt fine so I left it at that. It took several days for the pustule to go away. I hope you don't mind but I am writing to report this information in the event it may be helpful to you and I am also reporting it because I want to know if what I experienced could be considered an immune response to the vaccine? Another words, not an allergic response but an immune response ? I can find absolutely nothing about this on-line and no one knows what to make of it. Thank you.

Rash across face, part of her cheeks over her nose; Arm sore; Received two vaccine within 10 minutes of each other and now to be re-vaccinated again the second dose; not enough research can guarantee if that's safe; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL0140, expiry:Mar2021), intramuscular on 12Jan2021 at a SINGLE DOSE then intramuscular on 12Jan2021 at a SINGLE DOSE for covid-19 immunisation. Medical history included blood cholesterol increased, fistula, surgery on 18Dec2020. It was stated, "Sure, I am hoping you can help me. I am one of the legal guardians for our younger sister who has special needs. She is residing in a group home, group home in the city area she is currently been out of it because she has surgery. They have made arrangements for them to still ask for them to receive the first Pfizer Covid 19 Vaccination just this past Tuesday so I go from up there from my home in city and we had a problem in there they screwed up and ended up vaccinating her twice within 10 minutes. I asked the pharmacist, there I asked the RN what does that mean for her I mean I didn't know what that meant but normally we would sat for 15 minutes, they made her sat for 30 minutes. The nurse was there from the group home monitored her blood pressure and temperature and then we got in the car proceeded to drive 3 and half hour. They said just watch for temperature, labored breathing, take her to the emergency room call 911, the only thing she did have about an hour after she broke out that was "malar" (not clarified) rash across her face part of her cheeks over her nose that lasted for about 30 minutes. The next day her arm was sore which was going to happen but here is my question though she received two vaccine within 10 minutes of each other and now they are wanting her to be re-vaccinated again which would have been the second dose, supposedly on 02Feb2021. Nobody can tell me if that's safe or if that's okay, they can't guarantee, they all kept telling me, the nurse says, I called the pharmacist kept saying there's not been enough research to know if it's safe for her to get that next vaccine, so I don't know what to do." The reporter also stated, "IM, Both went for IM, first one went into her left arm and second shot was given in her right arm." The patient underwent lab tests and procedures which included blood pressure measurement: unknown result on an unspecified date, blood test: unknown result on 05Jan2021, body temperature: unknown result on an unspecified date, sars-cov-2 test: unknown results pre-surgery and post-surgery. The outcome of the event rash across face, part of her cheeks over her nose was recovered and arm sore was unknown.

Severe Left Leg, Hip and Lower left leg pain (Sciatic Nerve) it appears the vaccine may have irritated sciatic nerve pain. Left left leg numbness. Decreased mobility, difficulty sitting, walking, and even lying in bed. Started very quickly without andy known injury. Pain continued to worsen. Pain even worse after second injection. Now two weeks after second shot, the pain is going away. It is like the nerve irritation is subsiding. The way the irritation is subsiding makes it seem that the vaccination may have caused irritation to the nerve. After receiving 1st and continuing through the second vaccine, started having severe sciatica pain going down left hip and leg. Left leg pain and numbness. Thought I had done something to damage the nerve. Hurt to sit, hurt to stand and even hurt when in bed. The pain was so severe it caused issues with any mobility. Took Advil, Aspiring, Tylenol and nothing helped. Received second vaccine 1/12/2021 the pain continued and even got worse. It was to the point I couldn't even walk. I couldn't figure out how I had damaged the nerve. I am now thinking it was from the vaccine. I believe the vaccine irritated the nerve. The nerve pain is starting to go away. Normally if you have a sciatic nerve issue, it just doesn't go away on its own. I know there have been reports of severe back and neck pain. I believe it can irritate the nerves which cause severe pain. I wanted this reported in cases others complain of similar issues. The good thing it is improving.

arm pain; light headedness; abdominal pain; swollen, tender lymph node left axillary area; swollen, tender lymph node left axillary area; This is a spontaneous report from a contactable nurse (patient). A 60-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: EK4176; expiration date: unknown), via an unspecified route of administration left arm on 08Jan2021 08:30 at a single dose for covid-19 immunization. The patient medical history was not reported. The patient has no known allergies. There were no concomitant medications. The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: EK5730; expiration date: unknown), via an unspecified route of administration left arm on 18Dec2020 10:30 at a single dose for covid-19 immunization. The patient experienced arm pain, light headedness, abdominal pain and swollen, tender lymph node left axillary area on 08Jan2021 04:00 PM. The patient received treatment for the adverse events includes acetaminophen (TYLENOL) and ibuprofen (MOTRIN). The outcome of the events was recovered on in Jan2021.

FLU LIKE SYMPTOMS STARTED 3AM 1/29/2021 WITH GENERALIZED BODYACHE, LEFT AXILLARY PAIN, TENDER LEFT CERVICAL NODES, HOT AND COLD FLASHES AND HEADACHE. NASAL CONGESTION.

Headache; chills; shaking; weakness; tiredness; nausea; Joint pain; muscle pain; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 15Jan2021 at 13:15 (at the age of 60-years-old) at a single dose for COVID-19 immunization. Medical history included arthritis (knees), sulfa drugs allergy, poison ivy allergy (severe), and COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included meloxicam (MANUFACTURER UNKNOWN) and furosemide (LASIX). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced headache, chills, shaking, weakness, tiredness, nausea, joint pain, and muscle pain on 16Jan2021 at 13:00. The events were reported as non-serious. The patient underwent lab tests and procedures which included COVID-19 nasal swab: negative (test name: Binex) on 12Jan2021 and COVID-19 test: unknown results (post vaccination) on an unspecified date. Therapeutic measures were taken as a result of the events, which included naproxen sodium (ALEVE); it was reported that the treatment did not work. The clinical outcome of headache, chills, shaking, weakness, tiredness, nausea, joint pain, and muscle pain was unknown. The batch/lot number for the vaccine, BNT162B2, was provided and has been requested during follow up.

day 5 vertigo just morning dizziness all day better the next day. very tired no energy feeling crummy, migraines by day 6, 7 and 8... worst than normal and lasting longer than normal. usually get relief after 1 dose but it would take at least 2 before feeling somewhat better. some diarrhea, body aches. pain in my left arm and side around lung area. had chest x-ray on 1-11-21 clear. this all lasted until 1-27 or 1-28 felling a lot better today 1-29-21.... these are all the symptoms i had when i had covid in Nov. it was like having it all over again......

Temperature of 100.7, chilling, tired, brain fog, runny/stuffy nose. Took Tylenol and rested. Felt fine the next morning.

6 hours after vaccination: vaccination sight soreness and swelling - still have this symptom 3 days later 12 hrs after vaccination: Nausea, vomiting, headache, body aches, fever (100.7 at peak), chills. Lasted approximately 36 hours. 48 hours after vaccination: vaccinated arm has tingling sensation and weakness when raised, armpit lymph nodes tendor/sore - still have this symptom 3 days later. Took Aleve to alleviate symptoms. It lessened them somewhat but I was still not able to function fully for several days.

10 days after vaccine(1-31-20) I felt flushed in my face and sore throat. My temp was 99.5 which is abnormal for me because my normal is 96.5-97. I called my employer and had COVID test on 1-2-21 negative. Employer instructed me to go to get flu A and B test and strep test which were all negative on 1-3-21. On 1-5-21 had second covid test that was negative. On 1-6-21 video visit at PCP since I wanted to be released to go back to work. Had CXR(negative) and started doxycyline 100mg for possible sinus infection. Flushing sensation stopped on 1-9-21. No flushing sensation until 1-22-21(10 days after 2nd vaccine) but temp 98.5 at highest and I continue to have today. I continued to work through this second episode since I believe it was my body's reaction to the virus.

Developed chills, a low grade fever and headache on same day of her vaccination. The next day, she developed an itchy rash on her left arm which became panful. She saw her PCP who diagnosed shingles.

Dizziness and nausea within 7 minutes of receiving vaccine. 6 Hours after vaccine severe arm pain, sensitive to touch, movement and unable to lift arm beyond 45 degree angle. 17 hours after vaccine chills, fever of 102, muscle aches, severe headache, fatigue. 53 hours after vaccine, fever 101, severe headache, muscle aches, fatigue. Arm pain much less severe.

Late (11 pm ish) on 1/24/21 severe diarrhea started, lasted through early (8 am ish) on 1/26/21. On 1/25/21 I also had fever (highest was 101.4), chills, weakness, and aching bones. I also had a terrible headache that started 1/20 and lasted until 1/ 28 or 1/29. There was the normal injection site soreness on the evening of the first day.

Was okay Friday morning then stomach started getting upset Friday night and I tried to eat food to calm down. A slight headache was starting. The next morning I had a massive headache all day Saturday, by 8 PM it was a full-fledged nauseating migraine. The severe migraine lasted from 8 PM the previous night to 10 PM on Sunday night. By Monday I was doing better but a bit confused and having difficulty thinking. Now it is Wednesday and I am a bit exhausted and still having trouble thinking but doing so so much better! I am so happy to be feeling better!

Right upper arm/shoulder pain, including pain within joint. Limitations to move arm and weakness continue even after 1 month.

chills/major chills and could not warm up; was cold all night; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration in the right arm on 11Jan2021 15:00 at single dose for COVID-19 immunisation. Medical history included allergies to sulfa. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included citalopram, topiramate, zinc, and ergocalciferol (VIT D). On 12Jan2021 07:00, the patient started having chills in the morning that was gradually increasing throughout day. At 6:00pm, that patient had major chills and could not warm up. The patient got into the bed with numerous covers. She was cold all night. The last time she woke up was at 3:00am, and then when she woke at 6:00am, and she was fine. No treatment was received for feeling cold. Clinical outcome of the events was recovered on an unspecified date. Information about lot/batch number has been requested.

light headed; vertigo; feel flushed; headache; This is a spontaneous report from a contactable healthcare professional reporting for self. This 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=ELC142) via intramuscular on 13Jan2021 08:30 AM (vaccine location=Left arm) at single dose for Covid-19 immunisation. Medical history included allergies: Reactive airway to chemicals/perfumes/smoke. Concomitant medications included calcium carbonate, colecalciferol (VITAMIN D 2000), calcium, fish oil, echinacea purpurea root, olea europaea leaf, sambucus nigra fruit (ELDERBERRY ECHINACEA & OLIVE LEAF). The patient previously received first dose of BNT162B2 (lot number=EJ1685) via intramuscular on 23Dec2020 08:30 AM (vaccine location=Left arm) at single dose for Covid-19 immunisation. No other vaccine in four weeks. On 13Jan2021, the patient had a headache in the evening and took Ibuprofen before bed. She woke up about 3:30 AM 14Jan2021 to use the bathroom and had vertigo. She carefully maneuvered to the bathroom and back to the bedroom, drank some Powerade and sat on the bed for a bit before she slowly laid back down. She did feel flushed while experiencing the vertigo. She was able to get back to sleep for a few more hours. When she got up about 7:15 am she felt light headed but did not have any more vertigo. Treatment for event headache included Ibuprofen, no treatment received for other events. Patient did not have COVID prior vaccination, did not test COVID post vaccination, patient was not pregnant. The outcome of events was recovered.

slurred speech/ responded slowly to questions within 2 hours of receiving the vaccine; dilated pupils; "foggy."; This is a spontaneous report from a contactable other hcp. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3248), intramuscular on 19Jan2021 09:15 at a SINGLE DOSE for covid-19 immunisation. Medical history included hypertension and oedema. Concomitant medication included phentermine hydrochloride (ADIPEX-P), olmesartan medoxomil (BENICAR), furosemide (LASIX), amlodipine besilate (NORVASC), doxycycline (VIBRAMYCIN). The patient previously took Ciprofloxacin, Clopidogrel, Meperidine, Flagyl, Macrobid, Penbutolol and experienced drug hypersensitivity. The patient had the first dose of vaccine on 20Dec2020 (Lot number=EK5730). The patient exhibited slurred speech, dilated pupils and responded slowly to questions within 2 hours of receiving the vaccine. The patient felt like she just woke up from anesthesia and was "foggy" and 19Jan2021. The outcome of the events was unknown.

1/12 vaccine 1/13 woke up at 5-6am, shaking, chills, fever, dizziness and vertigo. ER later that day; blood work. Declined IV fluid. Monitored vitals. Body aches continued that weekend, went back to work the 14-15th but 'pushed it' to go back. 1/17 ER - blood panel; negative. Admitted to Inpatient to monitor heart and MRI of brain. still experiencing dizziness, 'disorientated'

12 hours after shot, all over body aches, sore arm and shoulder, fever. Shortly after, a headache occurred. The symptoms lasted all day and were mostly gone except for a small headache and fuzzy brain after 30 hours. All clear after about 36 hours.

Radiating pain the first night in the arm and in the muscle behind her breast. Continual head ache with fatigue and sore throat swollen glands since the vaccine in the evenings.

Client complaining of rash on upper chest and feeling flush . evaluated by EMS. BP 140/94, P 90, O2 97% Lungs clear.Client called family to pick her up and take to her PCP.

High heart rate. Vomiting, extreme fatigue. My body feels like is vibrating on the inside & shaking on the outside. Headache & extreme stomach pain. Which all of this has made it to where I'm unable to work.

Had trigger finger in right hand lasting 3 days -resolved. Began experiencing tingling and electrical impulses down both legs (no pain). This becomes worse with walking. Comes and goes throughout the entire day and wakes me up at night at intervals. Began 4 days after vaccine and has continued since.

high fever/100.1 degrees Fahrenheit/100.8 degrees Fahrenheit/99.8 degrees Fahrenheit; arm swelling; arm was very sore; headache; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249) via an unspecified route of administration in left arm on 20Jan2021 15:15 at single dose for COVID-19 vaccination. Medical history included ongoing coeliac disease diagnosed four years ago in 2017, allergic to dairy and corn, COVID in Nov2020. There were no concomitant medications, no other recent vaccinations and had started no new medications. The patient had a reaction with a high fever, a headache, and her arm was very sore after vaccination, that were similar to how she felt when she had COVID in Nov2020. The patient's arm was swollen and sore that evening on 20Jan2021. Her first fever was yesterday morning on 21Jan2021, probably at about 10:00AM or 11:00AM, and at that time it was 100.1 degrees Fahrenheit then later in the afternoon at 02:00PM it was 100.8 degrees Fahrenheit. She took Tylenol, applied cold moist cloth, drank lots of liquid for treatment, and she did sleep. Tylenol was clarified to be generic pain reliever, Acetaminophen 500mg. Acetaminophen 500mg, EXP Apr2021, LOT P114992, UPC: 1191717759. Her temperature improved after taking this medication, and it was 99.8 degrees Fahrenheit before bed. She hadn't taken any Acetaminophen this morning on 22Jan2021, but she took two tablets the first time yesterday on 21Jan2021 and then one tablet right before bed. She didn't go to the doctor for this. The outcome of events was unknown.

The symptoms began 10 minutes after administration of the vaccine. The symptoms were: anxiety and globus sensation pale and tremulous. Nurse noted that she had a 4mm hive above her lip. The treatment of the reaction was: o Epinephrine: x1 Transferred to ED

her face got swollen; lymph node right there it was extremely swollen and very tender and very painful; She had a lump at the site of the injection; chills; headache; flu like symptoms; This is a spontaneous report from a contactable consumer. A 60-years-old female patient received the second dose of bnt162b2 (BNT162B2; Lot # EL8982) vaccine , via an unspecified route of administration on 20Jan2021 at single dose for covid-19 immunisation . Medical history included hypertension. Concomitant medication included telmisartan (MICARDIS). On 30Dec2021 the patient received the first dose of BNT162B2 vaccine. The patient experienced her face got swollen on an unspecified date with outcome of unknown , lymph node right there it was extremely swollen and very tender and very painful on an unspecified date with outcome of unknown , she had a lump at the site of the injection on an unspecified date with outcome of unknown , chills on an unspecified date with outcome of unknown , headache on an unspecified date with outcome of unknown , flu like symptoms on an unspecified date with outcome of unknown. The events swollen face and lymph adenopathy were considered important medical Events. The remaining events were considered non serious. The patient stated she got the second vaccine shot of Pfizer on Wednesday the 20Jan2021. She got like a weird side effect like under her armpit it got really swollen and painful, like the lymph node right there it was extremely swollen and very tender and very painful. It still is but not as much. The next day the right side of her face was swollen The patient received Tylenol as treatment for the events. Follow up information has been requested.

02/05/21 Developed headache 3-4 hours after receiving COVID vaccine, along w/ metallic taste in mouth & tingling in right hand. 6 hours after COVID vaccine had tingling in both hands. 02/06/21 4 AM felt chilled. 8 AM had mild headache & fatigue, tingling in both hands continued all day. 02/07/21 Tingling in both hands continued. Then developed tingling in left foot & increased tingling in left hand. 02/08/21 Increased tingling in both hands, worse in left 3rd digit. 6 PM had increased tingling in left hand & tingling up into left elbow. 9 PM had increased tingling in right hand. 02/09/21 Tingling in both hands continued all day. Fingers feel cold off &on. 02/10/21 Tingling in both hands continued all day. Fingers feel cold off & on. Tingling in feet, left leg up to knee in evening. 02/11/21 Tingling in both hands continues, fingers feel cold in both hands. Tingling in feet.

2MIN AFTER DOSE DIZZY, VERY CONFUSED, SLIGHT CHEST PRESSURE, 30 MIN LATER SLIGHT SWELLING OVER EYELIDS, 1 HR LATER STILL VERY CONFUSED IN A FOG. VERY CONGESTED , SNEEZING, ITCHY EYES, STUFFY EARS, VERY CONFUSED. STRANGE FEELING INSIDE MY BODY - TINGLING . FEELING OUT OF BODY .... NOT MY SELF ...ITCHING. VERY CONFUESED AND VERY DIZZY FOR ABOUT 4 HR... SEVERED HEADACHES. NAUSAUES. 6 HRS LATER SWOLLEN FACE RIGFHT SIDE.

Sore arm at injection site. Itchy throat and itchy body. Extreme Fatigue. Heavy and fast heartbeat with severe pressure and chest pain. Ongoing muscle and joint pain that moves from location to location. Redness on chest and facial - cheeks.

shortness of breath, heart rate high, dizziness, low blood pressure, dry mouth, feeling faint, weakness, fatigue all over, numbness in feet and hands, two -three weeks of morning anxiety, difficult to operate a car, two tp three weeks stiffness in joints, and headache.

8:30 pm - extreme shivering, teeth chattering, extremities freezing cold, particularly the feet; severe body aches; injection site throbbing; upset stomach and a feeling of nausea. Temperature 100.2 at 8:45. Took temp every hour. By midnight temp reached 102.7. Head ache started. Couldn?t sleep on my left side because of the extreme pain around the injection site and down my left arm. Finally fell asleep around 2:30 and woke at 5:30. Fever was gone. Temp read 98.9. Body aches still present but not as severe. Arm pain had eased but head ache remained most of the day. Felt much better but just very tired.

Day 4 sudden feeling unwell, out of it, severe burning pain throughout whole body, joint pain , headache, cough, fatigue, upset stomach, diarrhea. Subsided in about 36 hours.

Extreme fatigue, nausea, chills, headache, dizziness 18-20 hours after receiving the 2nd vaccine for about 10-12 hours, then lessening to feeling tired, bouts of vertigo and occasional headache. Five days later on 1/25 I experienced blurry vision, nausea, confusion, dizziness, and impaired speech (to a co-worker). This lasted about an hour.

Within 30 seconds: Dry Throat, patient requested water, request was denied. 1 minute after vaccination: Coughing and difficulty breathing 2 minutes after vaccination: Patient refuses EpiPen administration stating she will not go to the hospital and not to call 911. 3 minutes after vaccination: Patient attempts to leave observation area to go use her own EpiPen in her apartment. 4 minutes after vaccination: Patient agrees to EpiPen administration into left leg and 911 is called. 5 minutes after vaccination: Patient continues to cough and clear throat. Patient throws herself out of her chair onto the floor while coughing. 6 minutes after vaccination: Patient hoarsely requests a second administration of EpiPen. EpiPen is administered into right leg. 7-10 minutes after vaccination: Patient is breathing easier however is forcing herself cough. 11 minutes after vaccination: EMTs arrive. Patient's HR: 141 bpm, SpO2: 96% 13 minutes after vaccination: Patient's SpO2: 99% 18 minutes after vaccination: Patient goes outside with EMTs 20 minutes after vaccination: Patient signs "Against Medical Advice" form - refusing to go to the hospital 22 minutes after vaccination: Patient is walked by to her apartment by EMTs.

facial swelling, facial stinging, flushing approximately 45 minutes after vaccination. Persisted ~12 hours

This is a spontaneous report from a contactable consumer. A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL1283, subcutaneous on 20Jan2021 15:00 at SINGLE DOSE for COVID-19 immunization. Medical history included diabetes, anaemia, blood pressure, cholesterol. Patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EU9899, in the left arm on 30Dec2020 15:00 at SINGLE DOSE for COVID-19 immunization and experienced swelling and redness at the site. Concomitant medications included liraglutide (VICTOZA), labetalol (LABETALOL), diltiazem (DILTIAZEM), valsartan (DIOVAN), rosuvastatin, metformin, aspirin and iron. The patient thinks that it wasn't given to her intramuscularly. This is a potential inadvertent subcutaneous administration of the BNT162B2. This patient received her second dose on 20Jan2021 on the side of her arm and reported that it was swollen, red, and hot, but has gotten 100 times better' over the last 6 days since administration. She was asking for efficacy of the incorrectly administered dose. It was further stated that in the middle of the night, her arm was red almost like a little bullseye and she said that she was getting burning, and pins and needles down her arm, and a fullness in her hand like her hand was swollen. She said that she still kind of feels it. As the days progressed on day 2, 3, and 4, the swelling got more intense, the circular red swollen area got worse to the size of like a small baseball. She was feeling okay other than that. Today was day 6 and it was not as red and was more black and blue, swelling went down 80 percent, she still feels a little bit of the pins and needles and the fullness in her hand. She said that there was like a big knot that was very hot. It was a hard like knot at the injection site. The injection site was really big, round, hot, red, and had a knot that lasted; adds it is still there but 99% better; and she had tingling down her arm with pins and needles in her hand. She noticed it was little red a couple of hours, like 8 hours later; but by the next day it was circular, more red, swollen, itchy, and burning down her arm. By the third day, the site had a big, red, hard knot; still burning down her arm and with pins and needles down her arm. She added that her hand felt like a fullness in her hand filled with fluid. By Friday the swelling at the site was gigantic. The site swelling is improved but the redness was more of a black and blue now. Her arm has been very dark red, discolored, swollen, painful and has nerve pain described as "hot tingling down the arm like pins and needles" to her hand. She states that she has a very large knot at the injection site. This was in her non-dominant arm. She spoke with two of the pharmacists that she works with and they looked at her arm and both felt like she may have received the injection subcutaneously instead of intramuscularly. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.

This is a spontaneous report from a contactable consumer. A 60-year-old female patient started to receive bnt162b2 (manufacturer unspecified), lot number: EL4238, via an unspecified route of administration in the left arm, on 21Jan2021 15:00 at SINGLE DOSE for COVID-19 immunization. Medical history included arthritis. Patient's known allergies are Penicillin, Peanut and Dairy. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. There were no concomitant medications. The patient's whole/entire arm was killing her; she was hurting across her shoulder blades down to fingers. Her elbow and wrist were hot and she was feeling a tremble in hand which she has never had before. She later added that her joint in elbow and shoulder was now reaching down to her arm. She couldn't even wear her watch today to her work, it felt swollen, like there was liquid in it. She also can't lift her arm, move and the pain was like going into her back. The patient was taking Aleve and Advil and "it doesn't take away all but it takes away enough that she can function." She also bought a topical ointment to help numb the area and she was wearing a pain patch on my back. The outcome of events was reported as 'not recovered'. No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.

lightheaded to the point of nearly passing out; nausea; general feeling of being unwell; lightheaded to the point of nearly passing out; cold sweat; loss of appetite; pain in upper shoulder/back area; pain in upper shoulder/back area; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL-9265), via an unspecified route of administration on 29Jan2021 12:30 in left arm, at single dose for covid-19 immunization. Medical history included chronic low BP, hypothyroidism, HRT, nasal allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included estradiol, levothyroxine sodium (SYNTHROID), multivitamin NOS (MULTIVITAMIN). The patient previously took amoxicillin; clavulanic acid (AUGMENTIN) and known allergies: Augmentin, being treated for nasal allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced nausea, general feeling of being unwell, lightheaded to the point of nearly passing out; cold sweat, loss of appetite, pain in upper shoulder/back area, on 01Feb2021 06:30. No treatment was received. The outcome of the events was recovering. Since the vaccination, the patient had not been tested for COVID-19.

During 30 minute observation after 1st dose of covid vaccine patient began experiencing palpitations/dizziness with BP of 157/99, requested transfer to ED for further evaluation. Began experiencing scratchy sensation to throat, difficulty swallowing with hoarseness of voice 5 minutes after vaccination. Received epinephrine 0.5mg IM once, protonix 40mg IV once, and solu-medrol 125mg IVPB once in ED. Patient was observed in ER for 3 hours and reported having EpiPen and Benadryl at home, was discharged with Prednisone 20mg, 2 tablets daily for 3 days.

Woke up during the night with chills that had my body shivering and a headache. Did not get up until morning because I didn't want to get out of the covers even though I was cold. Took some ibuprofen which helped with both the chills and headache. I had no energy and was very tired. I slept most of the day and woke up to go to the bathroom and take more ibuprofen. Towards the evening I could tell that I was feeling a bit better. I was able to take a bath, more ibuprofen and went to bed. Slept pretty well. Woke up once and took ibuprofen because of headache and body aches. Felt much better on Sunday. Was still tired and slept a good part of the day. My arm continues to ache, but is not really painful unless I try to lift it.

Felt burning towards the ears and cheeks and some numbness, reported not having any difficulty breathing but felt like she had to take off her mask to get "air", slight numbness in the arms and felt flushed.

I only had 1 dose on 2/16/2021 and got the reaction 1 week later 2/23/2021.. Not sure if that's possible but wanted to report it anyway. body ache, joint discomfort, migraine headache all day, fever, chills & nausea - this started about 10am on 2/23/2021 and lasted until 2am the following morning 2/24/2021. I took 600 mg of motrin every 6 hrs and 600 mg of tylenol every 4 hrs. I feel fine today

Other than mild soreness at the injection site she experienced no adverse reactions during the first 24 hours post-vaccine. On the second day after vaccination she developed chills without fever followed by the appearance of rhinorrhea and sinus headache that persisted for about one week. As she has a past history of genital herpes and this resembled her prodrome for recurrence she self-administered valacyclovir for several days. On the eighth day after vaccination she noted mild hand tingling. The following morning she awoke with numbness and hyperesthesia of the left shin that is still present.There was no persistent tingling and no pins and needles sensation

1010 pt c/o eyes draining clear fluid, generalized tingling, redness Dr notified and assessed order received to administer po benadryl 25 mg po 1030 symptoms resolving continued to monitor for additional 30 min. 1100 pt stable and symptoms resolved left premises this time.

As per Dr: 60 year old woman with history of MVA and back pain presents to office today with left arm pain and discomfort that started three weeks ago and has resolved but left her with tingling sensation in her third, fourth, and fifth digits on her left hand, symptoms started three weeks ago, hours after getting her COVID-19 vaccine. About a week and a half ago she began feeling numbness of her right leg going up to her upper abdomen with progressively worsening symptoms that have stabilized in the past several days. She also feels that her walking is off but cannot quite describe how or when it started. Exam notable for left-sided cervical myelopathy and decreased sensation on her right side up to a mid-thoracic sensory level. Of note she has a first cousin on her fathers side with multiple sclerosis and a more distant cousin on her mother's side with multiple sclerosis. Father with Parkinson's disease. I see that COVID-19 biofire came back positive. In light of this, COVID myelopathy is on the differential

Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: Patient explained she was very anxious, light headed, flustered, headache - more than 15 mins after the dose. She waited the 15 mins and when heading home, felt sick and returned to the pharmacy where the staff sat with her for an additional 30 mins

About 15 minutes after vaccination, patient reported symptoms of lightheadedness and feeling flushed. BP was high but otherwise vital signs within normal limits. Symptoms resolved.

Eyelids and face swollen, itching on the jaw, tingling sensation and possible stomach upset and some shortness of breath.

Horseness and cough after 30 minutes of monitoring. She has a history of anaphylaxis with bees and 2 antibiotics. She was given 25 mg of benadryl and symptoms improved. She was given instructions to take more benadryl in 4 hours to help with symptoms and to go to the ED if symptoms got worse

Sunday after administration, pt stated she started to feel her hear racing when going to bed, woke up with her heart racing in the am. Pt stated to experience tingling and burning in her feet that later traveled to her hands. Pt has a history of PVCs but noted an increase in the PVC frequency. Chest pain that was intermittent but lasted for 4-5 days. Continues to experience twitches and tingling feet to this day.

IMMEDIATE Strange warmth/tingling down left arm and then further down body Dizziness Headache Fatigue brief chills LATER & NEXT DAY Pain left arm Muscile aches, especially legs Brief episode of nausea Slight fever

Headache, Low grade fever, cough, loss of appetite, hot flashes, Lost my voice. Didn't feel well Friday night, started coughing and feeling unwell. I had a fever in the morning and had lost my voice but wasn't coughing anymore. Today no fever but no voice and I just don't feel well. No appetite today either.

My upper arm started feeling odd ... numbness in my left upper arm. I liken the feeling to when I?m having dental work done and my mouth/lips are numb. Through the night I developed some aching in my left shoulder. No treatment. Just an annoying feeling of not being able to feel my upper arm. It feels cold as well.

That evening starting to feel flu like symptoms. Today I feel like I have the stomach flu-body aches, headache, sore arm, nausea, 102 fever, joint pain

Pfizer. My right hand was swollen up like a catchers- mit. Very painful in thumb joint at a level 10. Was swollen for 5 days, then fever chills, body aches (fever 0f 100.2) Right hand was so painful was intolerable, truly had to wait for it to pass, nothing helped except for soaking in Epsom salt bath, which was short live. Have had arthritis in this thumb but not for approximately 8 years. Entire hand was swollen and not useable.

Swollen and very sore lymph glands in left armpit/chest with pain/tenderness on the underside of arm where injection was given; ice was used to reduce swelling and was alternated with heating pad. soaked in warm bath with epsom salts. relief was finally achieved by taking 1 Aleve liquid gel capsule - 220 mg. Swelling and pain began within 24 hrs after injection and pain increased intensely by hour 36. Some tenderness to touch still in lymph glands in armpit/chest and to underside of arm. minimal tenderness at actual injection site - no more than normal for a injection.

When I received the vaccine, the technician administering the vaccine had a difficult time pushing in the syringe. He moved it around a little bit and pushed hard again. After he pulled the syringe out, he kept tapping it, I guess to make sure all of it went into my arm. When he was administering it, I had a burning sensation as it went in. No one I know had this occur during their vaccine. Due to working environment, I need to know that I received the vaccine, and that something did not go wrong and it failed. Can you let me know if I still received the vaccine after experiencing this during the administration of the vaccine? I am very nervous that it failed and I am not protected. I had a slightly sore arm the evening of the vaccine, but it was gone the next day.

I started to get mild nausea within about 15 mins. then a chemical taste in my mouth. Later I was getting some sputum or phlegm coming up,, no cough, on short of breath no nasal discharge. During the night I woke up because the phlegm was much worse and abundant I wanted to sleep so at first was swallowing it, then it was so much that I got up and went to the bathroom. That is when I noticed that the palms of my hands were scarlet red. on both hands and not on the wrists or any where else. by morning it was gone but I did have diarrhea and still a cold mild nausea feeling in my stomach. Yesterday , 3 days later, still had diarrhea and nausea and was tired,,symptoms are not severe, but since these are not typical symptoms for me. I figured they will go away, but also I figured that I should communicate the reaction . I am scheduled for my 2nd shot in 3 weeks,

Left upper abdominal pain after receiving COVID vaccine radiating to left jaw rapid response, had patient remove mask and reported facial drooping. Transferred to ED for acute, painless, unilateral facial paralysis with no forehead sparing most likely secondary to Bell?s Palsy. Patient was monitored and discharged with prescriptions for valacyclovir 1000mg tid and prednisone 50mg qday x 7 days

Seizure: Sunday 2/28 @noon Migraines: 2/28 post seizure & 3/1 & 3/2 Pre-seizure symptoms: 3/1 & 3/2 ExtremeMuscle&Joint pain, fatigue, Ubrelvy 100mg 2/28 & 3/2, Ibuprofen 800mg, alt w/Tylenol 2-500mg, Rest/sleep most of days, warm showers, heating pads

5 minutes after receiving the vaccine, patient became flushed. She also stated that she had a sore throat without SOB or difficulty swallowing. She was able to drink water without difficulty. Her airway was patent and oropharynx was normal on exam. She had no stidor on exam. Patient was advised to seek care at the ED, but she did not.

Elevated blood pressure, headache (2 days), fever, EXTREME chills/shaking, congestion, loss of appetite, fatigue, could not lift arm.

At midnight after the shot I developed 99.9, chills, myalgia, severe migraine and all of it lasted 16 hours. I reported it to the nurse practitioner but did not want to see her because I knew it would resolve. I am a nurse and expected it would improve on it's own and it did. I did take Tylenol for the symptoms when they began. I work in a clinic.

SORE ARM, VERY TIRED, SEVERE HEADACHE, SORE MUSCLES ALL OVER, CHILLS, KNEE AND HIP JOINT PAIN, NAUSEA, SWOLLEN LYMPH NODES UNDER BOTH ARMS, FEELING UNWELL

COVID Vaccine Adverse Event Documentation After vaccination with COVID Vaccine Dose #1, patient developed evidence of Immediate (within 4 hours of dose) adverse reaction starting 3/5/2021 2:02 PM. Signs/Symptoms: Dry Mouth, Flushing, Lightheadedness, Nausea/Vomiting and Other (see comments) Reaction Comments: Skin blotchiness, dizziness, shaky, responsive but limp Treatment Administered: Cold Compress and Sips of Water Treatment Comments: Crackers, put in supine position Disposition: Home Disposition Comments: Next vaccine should be supine when receiving it. Additional Documentation: Pt became faint immediately after vaccine, warm, shaky and went limp I her chair but was responsive. BP: (!) 150/94 Pulse: 75 Supervising Provider Notified of Reaction: MD

I received vaccine. Noted at the 30 minute post wait vaccine site feeling a very slight like it was hard to take a deep breath 15 minutes after receiving the vaccine. I took my pulse. It was 90. I did not tell the medical monitor people. My husband drove me home after the 30 minute watch period was up. At 1:15pm I gave myself an albuterol neb to. Post tx home pulse ox was 95% pulse 96. No n/v, no itching. Breathing felt improved . I did a home peak flow reading which was 240. My personal best baseline is 350. I auscultated my anterior chest. Diminished, clear, no wheezing. I sat calmly. My husband noticed the left side of my face was mildly swollen. Amazing! For him to notice! it was very slight around cheek bone to jawline. I sent him to get otc Benadryl. I took 25 mg po . At 2:20 pm Pam was 300 p02 sat 98% pulse 96. Lips felt tingling, no swelling. Speech clear. Swallowing intact Drank water, low sodium soup. 3:30 pm did another albuterol next. Sat 95% after neb . Pulse 89. 20 minutes post neb peak flow reading 320. Started feeling chills. Temp outside a nice seventy degree day. Wrapped self 6 blankets,winter hoody fleece, heating pad and finally fell asleep. Family watched me sleep. Woke up 7pm. Still felt cold. Had fluids, urinated, breathing ok. Went back to sleep. 11 pm woke up, peak flow 300, did neb, took Benadryl wore my cpap machine and went to bed till today.

Pt experienced diarrhea at 0300 today with vomiting. Pt had body ache and feeling weak, Temperature was 101 at 0930 this morning. Pt has minimal coughing at this time. Current temperature is 99.9 The pt denies any SOA prior or currently at this time. The pt was informed to eat small amount of crackers as tolerated and fluids as tolerated. Get plenty of rest. Should sx's worsen or SOA occur, then call for an ambulance for assistance.

Received Pfizer COVID19 injection at 9:57 am on March 4 at the . As is usual for any shot or IV on me, I immediately tasted something weird in my mouth. It was not as metallic tasting as usual. More plasticy. Shot did not hurt. Was told to stay in 30 minutes waiting area.I did. The taste remained in my mouth. I left at 10:34 am feeling OK, except for weird taste. As I drove off the parking lot, I noticed that my mouth and tongue were tingling, with worst of it on my left side. My throat did not seem to be affected, so I continued driving. Some nasal congestion and coughing. The tingling turned into numbness in my mouth and tongue, all the way back to top of throat. I called my primary care doctor at 12:10 pm and left a message. I received a call back at 2:15 pm from nurse. She told me to take Benadryl and have someone take me to Urgent Care right away to get my vitals checked. I did not take Benadryl, as CDC said it could mask anaphylactic reaction. I called a friend and she took me . I noticed that my lymph nodes in my neck were swelling and painful. We arrived at 2:45 pm. My vitals were checked, heart and breathing listened to and was checked briefly for swelling in mouth and throat. There was no swelling. He said he had never heard of this tingling reaction and claimed it is just a side effect and not a serious reaction and that it would probably last a couple of days. He recommended that I watch for new symptoms and take Benadryl. That was $30. We left at 3:10. We left. I noticed that the numbness was spreading to my lips and up the left side of face and I was getting super tired. Also, my mid to lower back started hurting a lot. I took a Benadryl. 4:30 pm still have same numbness. My eyes got super dry and itchy. My head started to hurt. Some coughing. 5:10 pm dry eye and numbness, more swollen lymph nodes and chills. Pain in calves, upper back, same on both sides. 6:38 weirdly, from the bottom of my thumb to halfway up my arm there is pain. Both arms simultaneously. Worse on the left. 8:11 pm after bundling up and using a heating pad, plus extra heat, chills are lessened. Lymph nodes very sore in neck. Eyes are not quite as dry. Everything else is the same. 8:48 pm jaw really aches. Intestinal discomfort. Going to bed. 10:39 pm pain from jaw extended up into left ear. Upper part of throat hurts. March 5, 2021 4:00 am. Body aches have lessened. Left arm sore at shot area. 5:45 am eyes definitely dry, but not nearly as dry as yesterday. Numbness in mouth , tongue and face has lessened, but still uncomfortably present. Definitely worse on the left side. Little bit of tingling on the left, mostly on cheek from chin to ear. Headache gone. Lymph nodes sore and swollen . 7:00 am went on a walk. Noticed some achyness throughout body. Very tired. 10:51 am The tingling and numbness remain in my mouth, tongue and cheek up to my left eye. Very tired. Lymph nodes still swollen and sore.

Approximately 15 minutes after the vaccine was administered, the patient reported feeling lightheaded and tingling sensation of the face; patient also stated that she "feels like tongue is swollen." Patient vital signs were taken by EMS on site. Vital signs were within normal limits.

Swollen arm,unable to lift,unable to lay on,achy arm and wrist,tingly fingers from 7pm same day til 3:30 next day(Friday March 5)Slept all day,made appointment with Primary, took dosages of Ibuprofen

Extreme soreness in Left upper arm; chills; headache; tiredness; feeling like I had the flu; extreme weakness; rapid heartrate; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248), via an unspecified route of administration in the left arm on 29Jan2021 14:00 at a single dose for COVID-19 immunization. The patient's medical history included penicillin allergy, coronary artery disease (CAD), hypertension (HTN), pulmonary hypertension, sick sinus syndrome, hypothyroidism, hyperlipidemia, osteoporosis, chronic kidney disease (CKD), and diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included alprazolam (XANAX), venlafaxine hydrochloride (EFFEXOR), quetiapine fumarate (SEROQUEL), sertraline hydrochloride (ZOLOFT), isosorbide mononitrate (IMDUR), and metoprolol. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Jan2021 02:15, the patient experienced extreme soreness in left upper arm, chills, headache, tiredness, feeling like she had the flu, extreme weakness, and rapid heartrate. No treatment was received for the adverse events. Outcome of the events was recovering. The events were considered non-serious.

Lip tingling, palpitation, flushing and wheezing/slight SOB within 15-30 mins and sensation that she was unable to swallow while driving home. Used rescue inhaler when she reached home for relief. Symptoms now resolved. H/O asthma

left arm became red and tender 2 days after the shot- and has continued for a total of 3 days without change

Injection site pain, muscle pain, could not raise arm up high, chills, whole body ached, joints hurt, weak, mild consistent headache, nausea, skin sensitivity, feeling like a bad case of the flu for 30 hours. Getting better by Sunday evening. Still not 100% as of Tuesday. Slight headache comes and goes like a sinus infection would feel like.

This is a 60-year-old female who just received her second Pfizer dose of the Covid vaccine earlier today when she says she felt immediately a flushing of her left arm where she had received the vaccination and then some tingling and abruptly followed with difficulty swallowing tongue enlargement, and feeling like she had to "search for my air". This required her to turn her head leftward to assist in her breathing. She has no associated pruritus. She was given an intramuscular injection of epinephrine at the clinic where she received the vaccination and EMS was activated. She did not demonstrate any changes in her phonation or signs of stridor and there was no wheezing or signs of facial or oral swelling on arrival of paramedics. She received additional intramuscular injection of epinephrine and IV Benadryl and Solu-Medrol at that time followed by an albuterol inhalation treatment and transported here as a medical alert. She reports the symptoms are similar to what she is experienced with multiple bee sting allergic reactions in the past. She is never required intubation. She never develops any facial swelling or urticaria.

On day 2 of the second dose, had soreness, pain and swelling to injection site, also fever of 100.3, chills, body aches and weakness On day 4 after second dose had severe back pain, painful to walk, despite taking Motrin. Went to doctor and had MRI done. Then by early February started having insomnia, hard time falling asleep and staying asleep . I feel the second dose of vaccine might have caused my immune system to become over active. The back is now ok after rest and physical therapy but the insomnia still persist.

Vaccination was a 7:45 am Monday. On Tuesday at mid morning I started showing an allergic reaction. Itchy red spots all over head, ears and neck, some on lower part of body. Swollen lip. Took two benadryl at 1:45 am Wednesday . This helped to ease the itching. Had a headache so on Wednesday morning I took two Tylenol and made a Dr. appt. Also was weak and faintish on Wednesday when I got up. Dr's said to keep taking anti-histamines and report to ER if tongue or throat starts to swell.

acute chest tightness, chest pressure, SOB, severe cough, tachypneic, throat closing feeling hoarse voice, presyncope but epipen administered on site of vaccination location to avert syncope or cardiovascular collapse promptly. Symtoms occurred within 10 minutes of vaccine administration . Vaccine given 12:18 pm or 12:25 pm and symptoms within 10 minutes since in ER 12:30 pm but had received epipen en route before ER arrival since medical building was next to ER

burning itchy red bumpy rash started on left elbow, then spread to right elbow. Went to dermatologist on 2/24 for biopsy (gluten rash, psoriasis) and was prescribed Clobetasol 2x day. Rash dried up with skin flaking and peeling in about 5 days. Second vaccine received 3/4, no rash as of 3/10

mild headache, sore arm at injection site, mild nausea, mild weakness. sore arm immediately after injection lasting 2 days. Headache, nausea and weakness day after vaccination lasting 24 hours.

within a couple of minutes after receiving the shot, I felt a sudden flash of warmth throughout my body. Then my heart started racing. This lasted about a minute. I just sat there since I wasn't sure if this was normal. I started to feel like my heart was going back to normal so I just sat there for the specified 15 minutes. After I left and was driving home, I stated to feel a shortness of breath and difficulty getting air. I also felt like a hard to swallow. I was about 1 mile from venue so this happened with 30 minutes of receiving the shot. This only lasted what seemed like a short time and then I started to feel like I could get my breath. By the time I returned home I was breathing ok but my lips were a little tingly. I felt fine by 5:00 pm.

Enlarged lymph nodes following 1st shot-- Diagnostic Mammogram and ultrasound; Severe Diarrhea for 48hrs following 2nd shot. Pain in arm for about 4 days following both shots

My Arm Pit and my Breast on my right side of my body became so painful as if I had a major injury or surgery. Tylenol and Aspirin could not control the intense pain. The pain was excruciating!! I also had aches, fever, chills and tender lymph nodes in my neck. The excruciating pain last 3-4 days. 7 days later I still have tenderness in my breast and arm pit.

Tingling/numbness started in feet and then worked it?s way to the top of my head. The tingling/numbness lasted about 10 hours and gradually diminished from my feet up to my head. About 2 hours after the tingling/numbness started I felt my blood pressure or blood sugar start to fluctuate up and down for about 2 hours. I stayed in bed for this time period. I felt light-headed and scared. After about two hours, I felt stable enough to get out of bed and ate some food and drank some liquids. The numbing/tingling sensation seemed concentrated around my head for hours. I couldn?t really focus on anything. It felt like when your foot falls asleep. I felt as if I was having a neurological reaction because of the weird tingling numbness sensation. It felt like my nerve endings were firing all over; like having the chills without being cold. Although the biggest event was on 2/28, I felt the tingling ing/numbness in my arms on and off for at least another week. I?m scared to get the 2nd dose.

Nausea, diarrhea, dizziness, disorientation, shakes, headache, injection site pain - all started around 1 pm March 8 and subsided by 8 am March 9

Patient administered Covid Vaccine (Pfizer, 1st dose) at approximately 2:46PM. At approximately 1505 pt c/o nausea and ran outside. Pt awake, alert, respirations easy and unlabored, no distress noted. No vomiting occurred. Pt stated history of throat swelling and facial swelling/rash after PCN. 1510: Pt stated nausea resolved. Pt Diabetic and had not eaten lunch. Juice and crackers given, pt tolerated well with no difficulty. Respirations remain easy and unlabored, no distress. 1517: Pt clearing throat, c/o throat swelling, able to manage oral secretions, speaking in complete sentences. Pt to triage area via wheelchair by RN. BP 171/80 | Pulse 77 | Resp 17 | LMP 02/01/2013 (LMP Unknown) | SpO2 98% 1523: Pt awake, alert, c/o difficulty breathing. RN called for assistance 1526: 911 called. BP 184/84 | Pulse 82 | Resp 20 | LMP 02/01/2013 (LMP Unknown) | SpO2 100% 1528: RN called ED MD, Dr., verbal order received for Epinephrine 0.3 mg subcutaneous one time now. 1530: Epinephrine given per MD order. 1532: EMS crew on scene, Sac City 7, assessing patient, full report given by RN. During transfer of care, pt started shaking, full body, eyes closed, assisted to supine position on gurney by EMS crew, no injuries occurred, very short duration- pt aroused. Pt and her personal belongings to ED by EMS crew.

2:30 pm pain in left breast and arm pit. Around 3:30 pm slight headache lasting until 6:40 pm. 12:50 am woke to hot sweating and cold lightheaded and dizzy, nauseous and dry heaves. Rash on shot spot and surrounding area. Skin peeling at bandage area. 11:00 am shot area sore. Bandage area still a rash and slight peeling of skin.Dizziness is gone and nausea is gone. No headache

I have a swollen uvula with blood red spot on the side. It is hard to swallow and it burns. I will call my doctor tomorrow morning.

Patient presents with feeling lightheaded after she got the second dose of her Pfizer vaccine about half an hour ago. She is brought over here by staff at the vaccine clinic. She continues to have some shakiness. She denies any pain or shortness of breath. Symptoms are worse when she is sitting up. She has had syncopal episode in the past. Denies any chest pain.

Normal side effects except extreme pain at back and left kidney. Felt like I had been kicked in the kidney by a mule. Lasted Wednesday through Friday. Could not get comfortable.

PATIENT STATED IMMEDIATELY AFTER RECEIVING IMMUNIZATION THAT SHE HAD A "FLUSHING" FEEL, BUT THAT IT IS NORMAL FOR HER TO GET THAT WAY WITH CERTAIN THINGS. PATIENT WAS MONITORED BUT RECEIVED NO MEDICATION.

15 hours after vaccination sever diarrhea and vomiting, which lasted 8 hours. Chills and shaking. Fever that climbed to 102.7 and lasted 24 hours. Took acetaminophen. Fever back to normal on 3/16/2021, four days after the vaccination.

3/12 ? Got vaccine at 1:40 pm and within about 1-2 minutes, I felt a sensation of heat in my throat and upper chest. It got a bit worse and then improved over the next few hours. I also experienced a scratchy/itchy sensation in my throat and a slightly itchy feeling on the skin of my neck and upper chest. No wheezing or swelling. Took 25 mg Benadryl at bedtime. 3/13 ? Sensations continued, still fairly mild, but with occasional tingling on lips in addition to other symptoms. Took 25 mg Benadryl at bedtime. 3/14 ? Feeling about the same; still experiencing intermittent sensations of heat/scratchiness in throat and upper chest and occasional tingling on lips. Took 25 mg Benadryl at bedtime. 3/15? Symptoms continue to improve, but I?m still experiencing intermittent sensations of heat/scratchiness in throat and upper chest and occasional tingling on lips. Took 25 mg Benadryl at bedtime.

About 13 hours after receiving vaccine I awoke close to midnight feeling ill. I spent the next 3 hours having bouts of diarrhea every 5 to 10 minutes along with chills and feeling hot and abdominal pain. This morning on the 16 of March I feel okay with some fatigue and sore right shoulder at injection site.

Approximately 5 minutes post injection my blood pressure plummeted and I began to feel faint. I also started shaking uncontrollably particularly hands and arms. Vaccine administrator was immediately notified and they summoned the closest EMT. Emergency Services took my BO and pulse oximeter. A few minutes after the start of the symptoms. They explained that since my HR was at 84, BP was 110/68 and oxygen saturation was at 98% and I wasn't having difficulty breathing that I was not having an allergic reaction to the vaccine but a parasympathetic response instead. They sat with me until the shaking stopped approximately 15minutes later.

Patient reports having a history of anxiety. Stayed for 15 minutes, then went up to her apt. She came back down to report that she was having pain in her right breast (hx of Cancer in it) then it radiated to her right side down to her pelvic region. She reported feeling woozy/dizzy. She did not lose conciousness. HR was 80 regular, BP 164/92, lungs clear.

This patient was vaccinated approximately 1 hour prior to presentation here with her first dose of the Pfizer COVID-19 vaccine. She felt fine right after her vaccination but as she drove to her destination where she was going to take a walk, she started to develop left-sided facial burning and swelling. That prompted her to call her PCP in that office recommended she come back to the vaccination clinic to be evaluated. I evaluated her at approximately 2 PM.. She was feeling well for the most part with the exception of left-sided facial burning and swelling and a little bit of redness over her left cheek. She denied fevers, chills, itching, other areas of rash, difficulty speaking, difficulty swallowing, tongue swelling, lip swelling, wheezing, chest pain, or difficulty breathing. She recalls a penicillin allergy at age 5 or 6 but cannot remember the reaction. She has never reacted to a vaccine before. Initial vital signs included a blood pressure of 134/73, a pulse that was 70 and regular, and an oxygen saturation of 100% on room air. She had normal mental status and her lungs were clear. The left side of her face was slightly swollen over her left cheek as compared to the right with some slight increased flushing on the left side. There was no stridor, she was speaking comfortably, and her lungs were clear with good airflow. Her heart demonstrated S1 and S2 with regular rate and rhythm. I administered 2 doses of Benadryl, 25 mg with each dose about 15 minutes apart with her last dose at approximately 2:25 PM. I rechecked her vital signs at 2:50 PM and her blood pressure was 138/79 with a pulse of 70 and regular and an oxygen saturation of 99% on room air. Her lungs were clear and she was moving good air. I did take a relook at her face which was improved with decreased swelling. At 3 PM, because she was doing much better, I discharged her to home with instructions to use Benadryl 50 mg when she got home and then 25 to 50 mg every 4 hours today. If she develops any respiratory symptoms such as difficulty swallowing, cough, breathing difficulty, swollen tongue or swollen lips, as well as increased facial swelling, she will call 911 to be evaluated. She should not get the second Pfizer COVID-19 vaccine.

Within the first 30 min of receiving first COVID vaccine pt report feeling dizzy and nauseated. Pt taken to vaccine clinic observation area to be closely monitored. Pt placed on gurney and given water to drink. VS stable. Pt report headache 5/10, feeling sensitive to light, and nauseated. While in observation area pt reports feeling what she describes as "feeling weird wavey sensation over entire body, warm head, and cool body." Pt offered but declined to go to ED. explained risks and benefits to pt. Pt states that she drove herself to vaccine clinic. Pt advised that it it would be unsafe to drive herself home and advised to to contact husband for ride home. Pt called her husband to pick her up. After several min pt states stated that she was "feeling a little better" and "headache was also a little better" 3/5 on pain scale but still feeling dizzy and chest feeling a little tight. " Pt states having a history of Asthma. Pt again offered to be treated in ED and accepted. Pt transported to ED by gurney accompanied by three RN's.

my tongue was tingling and was slightly swollen; difficulty swallowing saliva but could swallow water; my tongue was tingling and was slightly swollen; I felt some tingling in my face; I felt light headed right after the shot; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection; Lot Number: EM9810), via an unspecified route of administration in the left arm on 04Feb2021 at 16:15 (at the age of 60-years-old) as a single dose for COVID-19 vaccination. Medical history included depression, anxiety and the patient was diagnosed with COVID-19 prior to vaccination. No allergies to medications, food, or other products. Concomitant medications received within 2 weeks of vaccination included 6 prescribed meds daily plus vitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient was not tested for COVID-19. Upon vaccination on 04Feb2021 at 16:15, patient felt light headed right after the shot. She waited 15 minutes and started driving home. she felt some tingling in her face. By the time she got home, 35 minutes after the shot, her tongue was tingling and was slightly swollen. She had some difficulty swallowing saliva but could swallow water. Her tongue was still slightly swollen the next morning but did not tingle. No seriousness criteria was reported. The patient did not receive any treatment for the events. The outcome of events was recovered on an unspecified date of Feb2021.

As I pulled up for the 15 minute wait period the symptoms started 5 minutes after I received my vaccine. A tingling feeling up my left arm to back of my neck. My neck stiffened and then my throat started to close. Not to where I can't swallow but just like when I eat food that I'm allergic too, it closes up. The nurse that was overseeing me was holding the umbrella over my car window with the rainfall. All of a sudden their was lightning & thunder. The nurse threw the umbrella because she was shocked from the lightning. She started to talk to all the other around her and forgot about me. Since I could still swallow I didn't get her attention. When she returned she asked me the time so I had to pull my phone out. She didn't know the time of my 15 minutes and sent me away. As soon as I got out of the parking area but still inside amusement park, I started to feel my cheeks becoming numb and my right eye was blurry. I quickly moved over to the side lane still inside of amusement park and waited. I called my husband and told him that with the heavy rain I didn't feel safe driving with my right eye being blurry. I waiting another 15 minutes before driving home. That evening the blurriness came back, my eye's & forehead was tender to touch but no headache. Only pressure in my head. My symptoms of closed throat, swollen cheeks, pressure in my head and blurriness continued on Friday, March 12th, Saturday, March 13th, Sunday, March 14th and Monday, March 15th. As of today, no other systems other than feeling my body has inflammation.

Just a few hours after receiving my first Vaccine, I started running a fever of 99.9, Got real sick at my stomach, started have Diarrhea, Severe Headache, My arm hurt really bad could not use it for a Day and 1/2. Just felt like I had been run over by a Bulldozer.

Pt in COVID-19 Observation Area complained of weakness to body. Per pt felt dizzy and anxiety earlier but better now. . B/P @ 141/92 02 Sat. @ 96-99%. Doctor evaluated pt rechecked B/P @ 100/50 02 @ 96-99%. After evaluation pt states less wekness to body. Pt keep in Obsrvation area.Pt felt better and wants to go home Doctor notifed. Instructions given to pt to go to Urgent care or E.R. @ Medical Center if sympyoms worsen and return tomorrow if s/s continue. Can be discharged. Pt accompanied to vehicle to daughter. Instruction given to daughter verbalized all discussed.

Pt. at the observation area felt a heat flash and dizzy, paramedics assessed pt. Once pt. was feeling better, paramedics released her to home.

The event began with me feeling extremely cold and unable to warm up. It later progressed to needle like sensations where ever touched. I do not remember the next week. Per my husband I had a sustained temp of 102 and was difficult to keep hydrated. My O2 sats remained stable. The following week I became unable to drink anything thicker than water. This has improved but continues to this day. My husband is a physician.

/o sore arm & fatigue since receiving the vaccine on Friday. Deveolped low grade temp on Monday, taking tylenol & ibuprofen PRN, No other complaints at this time. Advised to continue with Tylenol/ibuprofen and contact PCP if symptoms worsen.

Could stand, couldn't walk; Swollen lymph nodes in left arm; neck ache; Frontal headache; Heaviness and soreness in arms; Heaviness and soreness in arms; has a sore spot only where the COVID vaccine was; This is a spontaneous report from a contactable pharmacist (patient). A 60-year-old female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EN9581), via an unspecified route of administration on 04Feb2021 at 10:20 at SINGLE DOSE in left arm for covid-19 immunisation. Medical history included ongoing multiple sclerosis. There were no concomitant medications. The patient previously received the first dose bnt162b2 (Lot: EL3249) on 14Jan2021 for COVID-19 immunisation and experienced couldn't re stand. The patient experienced could stand, couldn't walk on 05Feb2021, frontal headache, heaviness and soreness in arms on 04Feb2021, swollen lymph nodes in left arm on 05Feb2021, neck ache on 04Feb2021 at 22:00, had a sore spot only where the covid vaccine was in Feb2021. Event details: The patient had the second COVID vaccine on 04Feb2021. Was fine that day. Had heaviness in her arm and little bit of headache. Was fine the day of the shot. 04Feb2021, felt a little heavy in the arm where she got the COVID shot. Received COVID vaccine in left arm. Drove home and was fine. Sat down and watched TV and had a frontal headache. Took Tylenol. By the time she went to bed, around 10:00 PM, her neck was so sore to turn from side to side. On top of her arms where shoulder pads would be is there the heaviness was. Both arms became sore. It was manageable and she took Tylenol. Eventually it went away. Friday morning 05Feb2021 when she got up, got to the point where she got out of bed and couldn't get up. There was no possible way for her to get up. Her husband had to buy her a 3-in-1 potty chair so she could just stand and pivot, seriousness was provided as disabling, could understand hospitalization, but confirmed she never went to the hospital. Could not rest that day or go back to the bathroom. Didn't walk anywhere. Was in a chair that she could sleep in. Husband bought her a potty chair. Was able to use the lift on the lift chair later that afternoon. Definitely debilitating. Sister who was an orthopedist nurse had to help her and secured she wouldn't fall. The patient had swollen lymph nodes only in the left arm on 05Feb2021. At time of reporting the patient had a sore spot only where the COVID vaccine was. It was not red. Only sure up underneath and when it was touched. The outcome of events could stand, couldn't walk, heaviness and soreness in arms was resolved on 06Feb2021, outcome of other events was unknown.; Sender's Comments: Based on available information, due to close temporal association, a possible contribution roe of bnt162b2 to the onset of "unable to walk" cannot be excluded. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Face begin to itch, then neck. About 20 minutes later started to notice large hives on face and neck. Very red and itchy. Went to pharmacy to get Benedryl and pharmacist suggested to go to ER immediately. Went to ER and was evaluated and kept for observation. No swelling of tongue or difficulty breathing. Stayed for observation and given prednisone (deltasone) . Given an epi pen and instructed to take benedryl. Hives subsided. No reactions since that night. Arm a bit sore but nothing severe. Seeing an allergist next week as followup.

Left side of left arm became numb, down side of arm and three fingers. Left side of left leg also felt numb but half as much as the arm. No treatment. It went away by 10 am the next morning.

This is a 60 year old female was brought into emergency department as cardiac arrest. Patient was seen at care now urgent care with the complain of epigastric pain associated with nausea vomiting and intermittent diarrhea. Patient received her initial COVID vaccine 2 days ago. History is obtained from urgent care chart. As per notes patient started nausea vomiting 6 hours post COVID vaccine administration. Patient was seen in urgent care for epigastric pain and nausea vomiting. Patient was found unresponsive at 0902 by tech. No carotid pulses palpated. CPR was started. Patient was brought into the emergency department with Lucas on. Patient was given 5 epinephrine prior to arrival. CPR was in progress. Patient was asystole. Resuscitation was continued in the ED. Patient was intubated in the ED by physician assistant 5 epinephrine 2 bicarb and 1 calcium chloride was given in the ED. Cardiac Ultrasound didn't show any cardiac activity. Asystole on the monitor. No corneal reflex people are fixed and dilated. Patient was pronounced at 1007 am

Arm was sore at bedtime. By the morning, I could barely move my right fingers. Very sore and tired the day after. I was incredibly sore everywhere - back,chest, hips, legs, neck... very hard to move. Around 5 PM the day after the vaccination, I became violently ill. Diarrhea, chills, feverish, sweating. etc. This lasted until about 3 AM on the 18th.

Day 1 (3/7): sore arm, mild headache, fatigue, nausea Day 2 (3/8): more sore arm, mild headache, fatigue Day 3: unable to lift left arm, headache Day 4: sore arm, 3" oval shaped red spot next to shot spot: swollen, raised, itch Day 5: arm better, red spot still itch Day 6: able to lift arm, less sore, red spot smaller, still itch, shot spot still itch too Day 7: arm almost back to normal, red spot diasppeared Day 8: all 10 toes red, swollen, extremely itch, unbearable especially at night Day 9 - 10: different toes itch more each night Day 11 (3/17): visited urgent care - diagnosed fungal infection Day 11: visited Primary Care Physician : referral to visit Podiatrist Day 13 (3/19): visited Podiatrist - diagnosis COVID Pfizer Vaccine side effect, prescription: Betamethasone

I had no side effects except a sore arm with both doses of the vaccine. Only this week I started to experience ringing in my ears (tinnitus) and I have never had that before. The only reason I thought it was related to the vaccine was that my husband experienced the same symptoms recently as well and he received both doses of Moderna vaccine in January. I find it very strange that we are experiencing these symptoms now after more than a month of getting a second dose of the vaccine.

5 minutes after the shot, a feeling of warmth went through my upper body to my head & my tongue was tingling. It lasted about 30 seconds. It happened again about 1/2 hour later (11:12 am) but not as strong or as long.

Felt lousy about hr after arm tender to lift up, ,headache,then jaw pain w worsened malaise,nausea, violent headache, chills fevers ,dry heaves, red and hot arm developed after couple days lasted about six days spread to 4x6 inches got itchy then sore to touch. Became vague and almost disoriented, had to sleep due to overwhelming fatigue w vile headache

Pfizer-BioNTech COVID-19 Vaccine EUA Date of Tuesday, Mar 16, 2021. Intense neuropathy pain in both feet and both lower legs mainly at night. Difficulty sleeping. This continued each night but during day of Friday, Mar 19, 2021 the neuropathy continued and the numbness and tingling migrated up into my legs and into my arms and hands but not as intense as in my feet and lower legs Tingling, shakiness felt in muscles is continuous now, not just at night. I was scheduled to have 2nd dose today but decided not to go through with getting it. Consulted with my APRN on phone and they advised to get 2nd dose and we would follow up if needed on neuropathy. I decided I did not want the 2nd dose.

COVID Vaccine clinic. Per chart review, pt received COVID vaccine at 1426. At approximately 1505 pt c/o nausea and ran outside. Pt awake, alert, respirations easy and unlabored, no distress noted. No vomiting occurred. Pt stated history of throat swelling and facial swelling/rash after PCN. 1510: Pt stated nausea resolved. Pt Diabetic and had not eaten lunch. Juice and crackers given, pt tolerated well with no difficulty. Respirations remain easy and unlabored, no distress. 1517: Pt clearing throat, c/o throat swelling, able to manage oral secretions, speaking in complete sentences. Pt to triage area via wheelchair by RN. BP 171/80 | Pulse 77 | Resp 17 | LMP 02/01/2013 (LMP Unknown) | SpO2 98% 1523: Pt awake, alert, c/o difficulty breathing. RN called for assistance, attempted to located on site MDs. 1526: No MDs on site, 911 called. BP 184/84 | Pulse 82 | Resp 20 | LMP 02/01/2013 (LMP Unknown) | SpO2 100% 1528: RN called ED MD, Dr., verbal order received for Epinephrine 0.3 mg subcutaneous one time now. 1530: Epinephrine given per MD order. 1532: EMS crew on scene, Sac City 7, assessing patient, full report given by RN. During transfer of care, pt started shaking, full body, eyes closed, assisted to supine position on gurney by EMS crew, no injuries occurred, very short duration- pt aroused. Pt and her personal belongings to ED by EMS crew.

I felt fine when I woke up. My left arm was very sore which also was the case after first vaccine. Around 10 am I developed chills and just did not feel great. My husband took my temp and the highest it got was 102.6 which is high for me since my baseline is 97.6 or so. I did not have a great appetite and felt very stiff when I moved around. I pushed fluids and took 3 naps Saturday. I have a low grade fever of 99 today but feel much better. Did take 2 naps and slept well last night. Took Advil with each meal and doing so today.

03/19/2021 - 4 PM I STARTED TO NOT FEEL WELL. LEFT WORK - WENT HOME , STARTED TO SHAKE REALLY HARD WITH COLD CHILLS. LAID DOWN WITH TWO BLANKETS AND WAITED FOR THE SHAKING TO STOP...THEN FELL ASLEEP. I AM GUESSING SHAKING WENT ON FOR A GOOD 1/2 HR TO HOUR. i WAS VERY WEAK TO GET UP TO GO THE BATHROOM. MY HUSBAND HELPED ME.

8.5 hours after vaccine injection, I suddenly began experiencing fatigue and extreme joint and muscle soreness. Initially I noticed my knees hurting with radiating pain up into my thighs. My head hurt, particularly at the back of my skull, near my neck. My neck muscles were sore, as were BOTH shoulders - my right shoulder (injection site) was only slightly sorer than my left shoulder. I called a 24/7 nurse associated with insurance company to ask if ibuprofen or tylenol were acceptable treatments for my symptoms. She told me I could take either and alternate if I felt I needed to maximize relief. I noticed the joins in my toes and fingers were hurting. It was frightening to experience tightness in my chest and back muscles. I never felt like my lungs were compromised, there was just a heaviness as the muscles seemed constricted. I felt a slight rise in my heart rate and experienced a few palpitations mostly because I kept pondering how much worse my symptoms could get. I was a little cold, so I decided to go to bed after drinking extra water (also a suggestion from the nurse). I slept for a few hours 10:00 PM - 4:00 AM then got up and called an advise nurse to report that my joint and muscle pain were not subsiding. She encouraged water and more painkiller. As the day wore on, I felt less achy and more shaky/jittery. My thinking was somewhat unclear - I felt a little dizzy, out of balance, off-kilter and brain "foggy." As I write this 36 hours after my injection, my symptoms are subsiding. Where I felt a little chilled during our cool and rainy afternoon, I now feel a wave of heat sort of traveling through my body. It isn't a fever - just an odd sensation that something is still going on.

By eight pm my left arm started hurting. At 2:30 am Sunday morning it was hurting so bad it woke me up. I could not raise my arm up past 6 inches. My left arm and side down to my waist was hurting. I took some Ibruprofen. Used a heating pad on my shoulder. Finally got back to sleep for a few hours. When I woke around 7:30 am, most of the pain had moved under my arm and to the front of my shoulder. I sat in my hot tub (100 degrees) for an hour and took more Ibruprofen. I was able to raise my arm up about half way. Was very tired. Went back to bed around 10 am and slept until 2:30. Had a headache and fatigue. Napped off and on the rest of the day. Today I can raise my arm all the way up, slowly. It is still painful to do so. The headache and fatigue are minimal.

Loss of appetite morning after vaccine, headache, body aches, chills, face flushed. Fever started afternoon. 99.4. Took Tylenol but it gradually rose to 102.3. Took 3 hours for fever to go down. By 5:30 fever was gone & I was feeling better. Next day I felt great but by three days later I had a fever blister & very sore, dry and stuffy nose which lasted two weeks. And headache as well. I?m thinking because of stuffy nose. I did have Covid last March/April 2020 so I have heard that I would have side effects.

Sialadenitis (salivary gland inflammation); glossitis (tounge inflammation); inflammation of the mucosal lining of the oral cavity with cherry red discoloration and swelling of the lips; inflammation of the mucosal lining of the oral cavity with cherry red discoloration and swelling of the lips; inflammation of the mucosal lining of the oral cavity with cherry red discoloration and swelling of the lips; Tingling; prickly sensation on tongue when eating; cold items felt opposite of what they should, more like burning sensation; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6202), via an unspecified route of administration in the left arm on 27Feb2021 12:45 as single dose for COVID-19 immunization. Medical history included known allergies to Sulph. The patient was not pregnant. Concomitant medications included aceclofenac (BIOFLEX [ACECLOFENAC]), calcium (CITRICAL [CALCIUM]) and vitamin D (VITAMIN D [VITAMIN D NOS]). On 01Mar2021 08:00, the patient experienced sialadenitis (salivary gland inflammation), glossitis (tounge inflammation), inflammation of the mucosal lining of the oral cavity with cherry red discoloration and swelling of the lips. Tingling, prickly sensation on tongue when eating, cold items felt opposite of what they should, more like burning sensation were also reported. Onset of symptoms Monday morning, symptoms peaked Wednesday evening through midday Thursday, greatly improved by Friday morning. The patient had a COVID test on Friday to be sure and it was negative. There were no treatment for events. No COVID prior vaccination. The patient had a COVID test type post vaccination-Nasal Swab (Covid 2 PCR) on 05Mar2021 which was negative. The patient had The outcome of the events was recovered on unspecified date in Mar2021.

At about 3:55PM my left arm, where injectiion was administered began tingling from upper arm to fingers. Pain to the back of my neck, a flush of warmth to my upper body and difficulty breathing. Felt like a truck ran over my chest. I was weak, dizzy and nauseous as well. The tingling sensation also affected both my legs. The RN took to their infirmary area and began taking my vitals. Vitals seems normal, Blood Pressure and Pulse were high. I am asthmatic but did not bring my inhaler with me. Because of my difficulty breathing, they decided to inject me with Benadryl which is all they had. After about twenty minutes, my breathing started to calm down and blood pressure began coming down as well.

Flu-like symptoms: headache, fatigue, dizziness, nausea, swollen lymph nodes, sore arm beginning the evening of injection. All symptoms, except sore arm, gone by morning. No treatment given.

I could actually feel the vaccine entering my blood stream above and below injection area. I had sharp pain on right upper side of my chest that came and went for several hours along with dizziness. Arm hurt so bad later that night from my elbow to my neck it woke me up and I took aspirin until pain died down some.

Started out with mild muscle pain with certain movement. Effects ability to drive and work. Saw Dr on 3/16/2021 Steroid cream, tylenol, and Xrays done. Informed that they might need to do an MRI. At this time she does not feel like it is getting any better. Sometimes hurts more than other times depending on activity, feels heavy and week. Can feel it poping and grinding with movement.

Within 1 hour after receiving vaccine, approx 45 min., Both ears suddenly felt as if I was on a plane and was blocked as you would feel by altitude change. I kept trying unblock by swallowing etc. That last 15ish minutes followed by a constant sound in both ears as if someone was rubbing sand paper back and forth in front of each year. That lasted 40-50 minutes. Approximately 32 hours after feel like I have to keep swallowing to unblock my ears. That altitude flucuation again feeling but not as bad as the first encounter. This was related to the vaccine. No doubt in my mine. Never had anything like this before unless on an airplane. Sand paper sound, never. I let my physician know tonight via email. In addition I felt dizzy within 5 minutes of receiving the injection. Subsided within 15 -20 minutes. Felt aloof the remainder of the day. Also arm hurt so bad the next day I had to cancel golf. Low grade fever plus headache

After I left the facility, driving home I notice that my back was starting to hurt, so I turned on the heat on my back . When I got home, I had difficulty getting out of my car. I sat in a chair and within the next few minutes I was not able to stand. My husband had to come help me get up and stand, there was pain across my lower back like pin needles and up part of my spine. I took Motrin and it helped it subside somewhat not much. The second day it continued but later started to ease a little but I was not able to walk upright. Third day, 3/24, it is starting to ease up and I am able to walk upright, there is still discomfort. I have contacted my physician to report the issue.

As per ER report from medical center, pt first reported tingling in tongue and lips 30 min post vaccine admin. Was discharged from ER, but returned later for general weakness/lightheaded, heart racing, felt throat was closing.

I was submitting my events daily on website and two days it tells me my session has expired and won't let me report anything. On Sunday night, March 21st, I started with very painful joint and muscle aches with fatigue. The next morning I felt terrible and could barely function, I had a bought with diarrhea that lasted almost the entire day and had no energy. I developed a large lump on my left clavicle area that seemed to be filled with fluid. My knees I had replaced are still very painful today ( 7 days post vaccine). I phoned my Dr. yesterday and they told me to take 1000mg of Tylenol 3 times a day. I am doing this now for the second day with some relief. I feel this is very unusual to feel this way 7 days after the vaccine. On day 1-2 the only symptoms were a sore arm from the vaccine. Saturday was actually a good day with no symptoms, the other symptoms started on Sunday. I feel like my heartbeat is irregular also but my BP is good. I would like to be able to to report daily on v-safe like I was the first few days.

Patient complained of feeling dizzy and hands tingling. One set of vital signs taken but patient refused a second set of vital signs. Patient felt fine after speaking with the medical doctor and went home.

Patient complained of numbness to her left hand. She reports "like hand is asleep but very faint." Reported the sensation began around 15 minutes after the injection. Patient stated that she is "not afraid and the sensation is still present but is barely noticeable." Patient did not have difficulty breathing and declined vital signs. Patient was advised by staff to login to report further symptoms and to go to the ER for worsening reactions.

Patient presented to emergency department at Hospital 30 minutes after receiving vaccine, complaining of tingling in tongue/lips. Patient was evaluated and given diphenhydramine and famotidine. Symptoms were improved and patient was discharged. Patient returned to emergency department approximately 4 hours later with general weakness/lightheadedness, rapid heartbeat, feeling of throat closing. Solu-medrol and IV fluids were administered. Patient felt much better and was discharged with a prescription for oral prednisone. **Note, this information was reported from patient's primary care office. An event have already been reported to VAERS for this patient by Hospital**

Received the first vac on 3/12 at 8:30 a.m.. I started feeling achy and tired by 4pm. By the next day, I had diarrhea and stomach upset starting by mid day. Since then, I have had daily diarrhea, lethargy, weakness, off and on headache, body aches (especially joints) and overall feeling of unwell.

received the Pfizer COVID vaccine dose 1 (lot ER8732, expiration 7/2021) at 0915. Patient reported to at 0920 that she was experiencing a bitter and metallic taste in her mouth and cramping in her wrist. Vital signs: O2 98%, pulse 73, blood pressure 140/82, respirations 16. Patient reported the taste had disappeared but the cramping radiated up her arm to the axilla. Medical conditions include: diabetes mellitus type II, pacemaker, status post stroke in 2017, hysterectomy in 2012, breast cancer in 1998 in remission, hypertension. Patient reported her normal blood pressure is 140s/80s. Medications: synthroid, levothyroxin, novolin, Humulin R, niacin and fish oil. Allergies include corticosteroids, codeine, sulfa, citric acid. Patient denied edema, tingling, pain, or dizziness. Patient reported she had not eaten breakfast and only drank a few sips of water with her morning medications. EMT advised patient to move arm and wrist continuously to promote circulation. At 930, offered Benadryl that patient declined, also advised patient to notify provider and signs when to contact 911. Patient drank approximately 8 oz of water, ate a small snack of pistachios, and reported improvement in cramping and taste resolved. At 940, vital signs: O2 97%, pulse 65, respirations 16, blood pressure 142/86. Patient reported symptoms had resolved. At 0952 vital signs: O2 99%, pulse 64, respirations 16, blood pressure 140/82. Patient left walking with steady gait.

After coming into the observation post vaccination, the patient told the nurse that she was itchy. The nurse assessed her and did not note any hives but did see scratch marks. Soon after, the patient stated she felt hot and had a headache. She quickly noted that her throat had begun to also hurt at that time. EMT's came over to assess her, per the nurses request the EMT's at that time suggested to the patient that she be further evaluated at the hospital. She accepted the transport to the ER.

neurothopy for 1-2 days; bone pain; Exhaustion; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via unspecified route of administration on unspecified date at age of 60 years old at single dose for COVID-19 immunisation. Patient had chemotherapy for ovarian cancer in 2020. Concomitant medications were not reported. Patient experienced exhaustion, bone pain, neurothopy for 1-2 days post first vaccine. Event took place after use of product. Outcome of events was unknown. Information on the lot/batch number has been requested.

sore arm, started to hurt in the afternoon treating it at home with cold pack, trying to avoid OTC medications

this was my 2nd dose. late afternoon & was feeling unenergetic. late that eve I felt achy, took 400mg ibuprofen before going to bed around 11pm. by 1 am on 3/24 I was running a fever, shivering & my inj arm was very sore/felt heavy. Took 400 more ibuprofen, fever reduced before too long. Also felt slightly nauseous during the night & into the day of 3/24. around 2 pm got a bad headache. more ibuprofen, still felt a little nauceous, tho that subsided in early a.m. 3/25. Also was coughing quite q bit most of 3/24, but that may have been due to allergy stuff. experienced some mild diarrhea on 2 occassions 3/24. Symptoms are fairly well abated by 10a.m. 3/25.

seven minutes after injection my skin felt flushed and hot around my upper back, neck, shoulders, I felt dizzy and then had diarrhea this continued off and on for several hours...in the ER they gave me steroid, saline solution for dehydration and pepcid. I had a headache and chills while in the ER. Went home and felt fine that night other than mild headache.

things went black; my blood pressure was alarmed was over 200 checked other arm same called there team ER member to triage still B/P high; severe dizziness; severe headache nausea; weakness; severe headache nausea; This is a spontaneous report from a contactable other healthcare professional (patient). An 60-year-old non-pregnant female patient received bnt162b2 (COVID 19, brand: Pfizer, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 07Feb2021 11:00 (Batch/Lot Number: EL9264) as SINGLE DOSE for covid-19 immunisation. Medical history included Stent in LAD (Left anterior descending coronary artery). Concomitant medications included losartan potassium, lorazepam (ATIVAN), acetylsalicylic acid (BABY ASPIRIN) and furosemide. It was reported that, within 15-20 minutes went to stand up severe dizziness and things went black started to get severe on 07Feb2021 at 11:15 AM. On 07Feb2021 at 11:15 AM, Headache, nausea Nurse Practitioner that gave shot took her blood pressure was alarmed was over 200 checked other arm same called there team ER member to triage still B/P high and she could not stand up due to weakness dizziness apparently they called Paremedic/EMT advised in her best interest to be seen in Emergency department. they did not how ever ask if she belonged to a ambulance company which she do so know she have a bill of about 1,500 with ambulance company. was in the ED for about 4 hours till blood pressure can down. was given medication for nauseas, felt like she was hit by a truck. Patient had Cardiac montering/medication. No covid prior to vaccination. No covid tested post vaccination. Outcome of events was recovered on an unspecified date in 2021. No follow-up attempts are possible. No further information is expected.; Sender's Comments: The events assessed as possibly related to the suspect drug BNT162B2______ based on strong temporal association, but consider also possible contributory effects from patient's medical history and/or concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

1-After 5 minutes of taking the vaccine I started to sneeze few minutes later it pass. At about 12midnight My arm was sore and in pain and very warm to the touch 2- on Tuesday morning I was very cold and very tired . 3- Around none or so I notice my self cleaning my mouth the left side , it feel like you just where out of the Dentist , like went you anesthesia from the dentist is running out. I have feeling but it almost feel like my drooling like my saliva is out of my mouth and also my left eye felt heavy and at first very watery and the dry . My left side of my mouse feel different and I?m connately cleaning my mouth.

On 3/18 Started out with arm and shoulder feeling hot. Then Excruciating pain in shoulder and all down the arm from 3/19 and still continuing today 3/27. Took Tylenol and used ice on shoulder and arm. Had a massage and stretching done on 3/23 didn?t help much. Contacted my doctors office on 3/23 and have an appointment for 3/31. The symptoms I?m feeling is that of SIRVA. Went to urgent care on 3/26 and was told that ?that is a symptom of the vaccine, give it another day?. Told them it was over a week and the pain I?m feeling is nerve pain. I was told there was nothing they can do for me there. Still feeling the pain today. Still icing and using Voltaren gel to help with inflammation.

Pain in left arm for about 30 min. followed by numbness in hand, then ring finger fingertip completely white that lasted about 10 min. Once color returned I soon became dizzy and weak feeling in my legs followed with vomiting. I then felt a little better with mild light headedness.

Severe cramping, bloody diarrhea, dry heaves. It calmed for a week, now I have cramping and bloody diarrhea again.

Within four hours of shot, low grade fever, 101.4, chills, nausea, exhaustion. Asleep by 9:00p.m., slept 13 hours, On March 17, woke at 10 am. Nausea, fever, chills gone, but totally exhausted with burning sensation at shot site and soreness in upper right arm. Remained in bed all day, asleep by 6 pm. Remained exhausted through March 23. Any physical activity caused shortness of breath and further tiredness. Exhaustion dissipated by March 24, 2021

soreness in arm. Chills, fever as high as 101.8, body aches, fatigue. Fever continued the entire next day along with fatigue. Today, March 27th, I have woken up feeling better, no fever.

Patient received 2nd Pfizer COVID vaccine today; completed 15 min RN observation; however, described to nursing staff she was starting for feel dizziness, tingling of hands, feet and " sudden odd, metallic taste" in mouth. A/O x 4 VS stable; reports dizziness, tingling to hand and feet bilaterally. Patient was assisted w/transfer from chair to wheelchair and transported to UC department accompanied safely by RN. RN/COM advised of incident.

Patient walked to medical tent complaining of itchy, blotchy skin chest and hand; voice breaking; throat uncomfortable, shaking BP 164/74 P 111 02 97%. Epi 0.3mg IM administered transferred to EMS for hospital transfer.

Site: Pain at Injection Site-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: vomiting-Severe, Systemic: Nausea-Severe, Systemic: Shakiness-Medium, Systemic: Vomiting-Severe, Systemic: Weakness-Severe

Heart rate increase Blood Pressure increase Chills Fever Headache Body Ache Tight Chest Lethargy Weakness

The next day I felt it was allergies, sneezing etc. I was told go to take a test took pcr and it came back two days later positive for covid. 24 hours after 3nd vaccine. Also have pain in left breast Under arm where shot was given

Shortness of Breath; Urticaria; Bronchospasms; Flushing; redness; This is a spontaneous report from a contactable consumer (patient). This 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot EN5318) via an unspecified route of administration in left arm on 09Mar2021 at 10:00 AM (at the age of 60-years-old) at single dose for COVID -19 immunisation. Medical history included systemic lupus, asthma, rheumatoid arthritis, thyroid cancer. She had allergies for antibiotics, pneumovax and morphine. She had taken other medications in two weeks. No other vaccine in four weeks was received. She experienced urticaria, bronchospasms, itchiness, shortness of breath, flushing/redness on 09Mar2021 at 10:15 AM. The adverse event was resulted in emergency room/department or urgent care. She was treated with IV fluids, benadryl, decadron and solumedrol. She did not have COVID prior vaccination and COVID tested post vaccination. Outcome of events was ecovering. No follow-up attempts are possible. No further information was expected.

her arm was extremely sore; unable to move left side of neck/unable to move arm; She felt unwell like she had the flu/sick; nose running; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198), an unspecified route of administration, administered in left arm on 25Feb2021 (at the age of 60-years-old), as single dose for COVID-19 immunisation. Medical history included lupus from 2018 to an unknown date, Cushing's syndrome from 2018 to an unknown date and ongoing Hashimoto's disease. The patient had also allergies. Concomitant medications included ibuprofen (ADVIL). Patient reported that within 2 minutes of getting the vaccine her nose was running. Two hours later she started to feel unwell. Her nose was still running. She was not sure if this was from the vaccine or because of her allergies. She felt unwell like she had the flu. She was sick and progressively getting worst. She was having reaction to the injection. On 26Feb2021 she woke up around 3:00 am and was unable to move the left side of her neck or her left arm. She still has some neck stiffness. She had small incidences for 3 days after. She felt paralyzed. She was unable to move her arm because it was completely painful. She didn't panic that her arm was extremely sore. She was able to move it. Caller added that she though she had Covid when she got the vaccine and didn't know it. She was sent t an EMS station to be tested. She was given the rapid test on 03Mar2021. Within 15 minutes she was told the result was negative. They sent out another test the same day. On 06Mar2021 she received negative results. She was scheduled to get the second dose on 18Mar2021 at 11:00am. The outcome of events 'she felt unwell like she had the flu/sick' was not recovered, nose running was resolving, unable to move left side of neck was resolved on 28Feb2021, unable to move arm was not resolved, the outcome of other event was unknown.

3/29/21 around 6pm -Light-headed, dizziness, off-balance when walking, numbness on right side of face, nausea and vomit once. Went to ER around 12:30am on 3/30/21. Admitted to the Hospital from 3/30/21-3/31/21.

she thought she was getting Bell's Palsy; Lymph nodes swelled; This a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 19Mar2021 17:30 (at the age of 60years) as single dose for Covid-19 immunization. There was no medical history; no known allergies. The patient is not pregnant at the time of vaccination. Concomitant medications included colecalciferol (VITA D); ascorbic acid (VITAMIN C); fish oil; ubidecarenone (COQ10); magnesium; and zinc; all taken for an unspecified indication, start and stop date were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that her lymph nodes swelled on the same side where she received the shot. Also, the left side of her checks down to neck and shoulders felt weird, she can't quite explain the feeling; she thought she was getting Bell's Palsy which is one of the adverse reactions. She was alarmed as she was unaware of the swelling of the lymph nodes. The adverse events occurred on 19Mar2021 (16:30). There was no treatment received for the adverse events. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was recovering. Information about lot/batch number has been requested.

Sore left arm at injection site; Tingling feeling on forehead; Slight headache; neck pain; This is a spontaneous report from a contactable Pharmacist. A 60-years-old female patient received BNT162B2 ( BNT162B2, Formulation: solution for injection, Batch/Lot Number: EL3247) first dose via an unspecified route of administration, administered in left arm on 18Feb2021 9:15 as single dose for COVID-19 immunization. Vaccination administered facility Workplace clinic. The patient medical history included Osteoporosis; irritable bowl syndrome. The patient concomitant medications included : Citracal; Centrum; Vit D (ergocalciferol); Colace; Evening Primrose (oenothera biennis), ascorbic acid, biotin, calcium carbonate, calcium pantothenate, calcium phosphate dibasic, chromium picolinate, colecalciferol, copper sulfate, cyanocobalamin, ferrous fumarate, folic acid, magnesium borate, magnesium oxide, manganese sulfate, nickel sulfate, nicotinamide, panax ginseng root, phytomenadione, potassium chloride, potassium iodide, pyridoxine hydrochloride, retinol acetate, riboflavin, sodium metavanadate, sodium molybdate, sodium selenate, stannous chloride, thiamine mononitrate, tocopheryl acetate, zinc oxide (CENTRUM ENERGY). On 18Feb2021 10:00 patient experienced with sore left arm at injection site (vaccination site pain), tingling feeling on forehead, slight headache, and sore neck on left side. The outcome of the event was recovering. Follow-up information was received on (25-MAR-2021): No new medically significant information was received on this case.

12-48 hrs post vaccine: nausea, fever, headache, muscle aches, malaise; took tylenol; 48-96 hrs post: malaise; 5th-10th day post: coronary vasospasms, malaise, arrhythmia; took nitroglycerin patches, nitro bid paste; 11th day: met with rheumatologist, started medrol dose pack, improved spasms for a short time, 13th day: afib symptoms and Apple Watch reading noted by patient; 15th day spasms began again and increased symptoms of afib: saw doctor in office for EKG showing afib; met with cardiologist ordered increase in diltiazem and second medrol dose pack; first 48 hrs on second dose pack improved spasms, by 3rd day spasms significantly increased and constant afib w headache, dizziness, malaise. Visited ER, admitted. cardio version. Reduced dilitiazem, reduced ramipril, increased isosorbide. Continued symptoms with waxing and waning of spasms and atrial fibrillation . Although this is a pre-existing chronic condition, Afib without relief is not normal. Spasms without resolution not normal nor have I experienced an episode of this duration ever.

Allergic reaction . Tremors. Ataxia. Spent 36 hours in ER with violent tremors, the tremors lasted 4 days follow by burning and painfully legs especially, in calf area made walking painful. As of this report legs still painful.

Hives including 1 that was blister like; Redness on arm; itching; arm soreness; This is a spontaneous report received from a contactable consumer. A 60-year-old (age at vaccination) female consumer reporter for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number; ER8727) via an unspecified route of administration on 23Mar2021 at 11:45 am at single dose on left arm for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Vaccine was administered at hospital facility. Patient's medical history included COPD mild (Chronic obstructive pulmonary disease) and allergies to medications, food, or other products (unspecified). Concomitant medications included (received within two weeks of vaccination) inhaler and vitamins (drug name unspecified). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient experienced Hives including 1 that was blister like, redness or arm, itching and arm soreness on 23Mar2021 at 01: 15 pm. Self- warm compression initially then iced was the treatment given. It was unknown if the patient was diagnosed with covid-19 prior to vaccination. Patient was not tested for covid-19 since the vaccination. The outcome of events was unknown. information on lot expiry has been requested.

My throat was itchy in between that half hour my voice started to change; my throat felt worse; I have wheezing in my lungs; I still have problem swallowing a little bit; My throat was itchy in between that half hour my voice started to change; my throat felt worse; This is a spontaneous report from a contactable consumer (reporting for herself). A 60-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 15Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included anxiety, depression, neuralgia, heart, blood pressure issue and lot of allergies. Concomitant medication included levothyroxine; atorvastatin calcium (CHOLESTAT [ATORVASTATIN CALCIUM]); pantoprazole; ciprofloxacin hydrochloride, tinidazole (FLOXAZOLE); aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]); lubiprostone (AMITIZA); thioctic acid (ALPHA LIPOIC ACID); baclofen; linezolid (ZENIX [LINEZOLID]); ascorbic acid, calcium, minerals nos, retinol, tocopheryl acetate, vitamin b nos, vitamins nos, zinc (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]); rosuvastatin calcium (CRESTOR); docusate sodium (STOOL SOFTENER); benazepril hydrochloride, hydrochlorothiazide (BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) taken for heart; desvenlafaxine succinate (PRISTIQ) taken for anxiety, depression; citalopram; venlafaxine hydrochloride (EFFEXOR) taken for anxiety; escitalopram oxalate (LEXAPRO); cyclobenzaprine; gabapentin taken for neuralgia; metoprolol taken for heart; amlodipine taken for blood pressure issue; magnesium oxide. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Feb2021 for COVID-19 immunization and experienced pulse rate would not go down. On 15Mar2021, it was reported that they had it done at the hospital, then after 15 minutes, her throat was itchy the may say another half hour in between that half hour, her voice started to change and her throat felt worse. They walk me down to the ER my throat was hurting then slowly they gave me Epi Pen and they injected in an IV with steroids. The have wheezing in her lungs and spent the night in hospital for observation. They did all kind of blood work, when she was placed in ER. The patient reported that she still have problem swallowing a little bit and voice changes after talking. The outcome of the event "still have problem swallowing a little bit" was not recovered while the outcome of the other events was unknown. Information on the lot/batch number has been requested.

On 3/31/21 woke with severe skin pain on entire left thigh. On 4/4/21 the pain continued and then there was a rash all around my thigh. The pain is still present and the rash has gotten worse. I went to my doctor on 4/6/21 and he says the event is caused by the vaccine. He said the symptoms resemble shingles but also varies from shingles.

shortness of breath, chest pain, altered mental status, weakness, hallucinations, admit to hospital and discharged on 4/2

Sickle cell crisis; She said she was unable to touch her collar bone because of the pain; pain along her heart, collar bone area, and ribs; Hot flash on the left side of her head preceded the headache; Headache; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received first dose of BNT62b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 12Mar2021 (Batch/Lot Number: EN6206) as single dose for covid-19 immunisation. Medical history included sickle cell anaemia diagnosed when she was a baby from an unknown date unknown if ongoing. The patients concomitant medication included unknown injectable medication the patient stated she was given injectable medication for 2 tests, 1 on 23Feb2021 and 1 on 26Feb2021. She said she didn't know the name of the medications given to her and the tests were ordered by her cardiologist. There was no history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). The patient experienced sickle cell crisis on 18Mar2021 headache on Mar2021, she said she was unable to touch her collar bone because of the pain on an unspecified date, pain along her heart, collar bone area, and ribs on an unspecified date, hot flash on the left side of her head preceded the headache on an unspecified date. The patient was hospitalized for sickle cell crisis from 19Mar2021 to 20Mar2021. The patient was still had sickle cell crisis pain along her heart, collar bone area, and ribs. She said she was unable to touch her collar bone because of the pain. She said she also had a headache. She clarified the headache started a couple days after she had the COVID-19 Vaccine. She said a hot flash on the left side of her head preceded the headache. She said she still had a headache, and some days her headache was better. She said yesterday (24Mar2021) her headache was so strong. She said the headache was on the left and back side of her head, but particularly strong on the back side of her head. The patient went to the Emergency Room after midnight on 19Mar2021. She said she spent the night at the hospital as an inpatient, and then was discharged by Saturday (20Mar2021) afternoon, around 14:30-15:00. She said she was given Morphine for pain, and was on an IV, and took her regular medicines. She said she did not know the name of the IV fluids that were given to her. The patient underwent lab tests and procedures which included cardiac stress test and electroencephalogram result was unknown. The outcome of event hot flash on the left side of her head preceded the headache was unknown and outcome of all other events was not recovered, Information on the lot/batch number already available. Further information has been requested.

vomiting; diarrhea/Lingering diarrhea into second day; ringing in my left ear. LOUD!; excessive urination; eyes feeling like they were popping out; tunnel vision; 104 fever; severe chills and quaking; severe chills and quaking; the worst headache in my life/slight headache on the back of my head, and continued into today; felt like broken shins; hip joints on fire; This is a spontaneous report from a contactable consumer herself (patient). A 60-years-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 22Mar2021 (Batch/Lot Number: EN6204) Solution for injection as Single Dose for covid-19 immunisation. Medical history included asthma, mild HP (Hypersensitivity pneumonitis) and I am fat. Concomitant medications included lovastatin, eszopiclone (LUNESTA), lisinopril and gabapentin. The patient previously took first dose of BNT162B2 (EN6198), on Left arm on 27Feb2021 for Covid-19 immunization. On 23Mar2021 02:00 patient experienced 104 fever, severe chills and quaking, the worst headache in my life, what felt like broken shins another friend said she had this as well, hip joints on fire, eyes feeling like they were popping out, vomiting after hours 26, tunnel vision, excessive urination, diarrhea started at hour 28. Lingering diarrhea into second day, slight headache on the back of her head, and continued into today, ringing in her left ear. The patient underwent lab tests and procedures which included body temperature: 104 on 23Mar2021. Patient did not test covid post vaccination. Patient did not have covid prior vaccination. The outcome of all events was recovered with sequelae.

Systemic: Headache-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details: Patient said she experienced left side numbness, slurred speech, severe neck pain, and a headache. She said she had stroke like symptoms but after being hospitalized for 3 days and having a CT scan performed stroke was ruled out.

Bells Palsy right side of face; This is a spontaneous report from a contactable consumer (patient). This 60-year-old female patient (patient was not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number En6208), via an unknown route on 15Mar2021 at 12:00 pm (at the age of 60-years-old) at single dose on the left arm for COVID-19 immunization. Medical history was none. The patient did not have allergies to medications, food, or other products. Relevant concomitant medications patient received within 2 weeks of vaccination included pantoprazole 40mg. On 15Mar2021 at 12:00, the patient had Bells Palsy right side of face. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment received for the event. Outcome of the event Bells Palsy right side of face was recovered in 2021. Follow up attempts are needed. Information on the lot/batch number has been requested.

Patient had her first covid vaccine injection at 0722 this am. She was escorted to the observation room where she told her nurse that she was experiencing tingling and numbness on the right side of her face from the nose down to the middle of her lip including half her tongue at 0730. Patient verbalized she had a TIA 10 years ago and this is how she felt when she had that event. She states she has a history of hypertension and a recently diagnosed aneurysm in her spleen. vital signs were obtained blood pressure 168/121, Heart rate 68, O2 sat on room air 99 % She denied any pain. Asked patient to stick her tongue out and it was midline before vitals slightly deviated after vitals were finished. Patient then states she feels like her face is swelling on the right side. ER was called. Patient taken to ER by wheelchair for follow up evaluation. Event documented on patient consent and event reported. Patient later admitted to hospital.

appendix had ruptured; diagnosed with appendicitis; could barely stand; I felt tired; sore arm; entire intestinal tract and stomach became hard; extended and felt like it was on fire and was extremely painful; vomiting along with diarrhea; vomiting along with diarrhea; pain and burning in my stomach and back; pain and burning in my stomach and back; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 29Mar2021 12:15 (Batch/Lot Number: EP6955) as single dose (at the age of 60-year-old) for COVID-19 immunisation, administered at Pharmacy or Drug Store. Medical history included known allergies: Sulfa drugs, aspirin cordisone. Patient had not COVID prior vaccination. Patient was not pregnant. Concomitant medication(s) included thyroid (ARMOUR THYROID) taken for an unspecified indication, start and stop date were not reported. The patient previously took aspirin [acetylsalicylic acid] and experienced drug hypersensitivity, cortisone and experienced drug hypersensitivity. No other vaccine in fourweeks. On 29Mar2021 19:30 the patient experienced she felt tired, sore arm, entire intestinal tract and stomach became hard, extended and felt like it was on fire and was extremely painful, vomiting along with diarrhea, pain and burning in my stomach and back. On 31Mar2021 the patient experienced appendix had ruptured, diagnosed with appendicitis, could barely stand. The patient was hospitalized for appendix had ruptured and diagnosed with appendicitis for 2 days. The events were considered serious as per hospitalization, disability, life threatening. Therapeutic measures were taken as a result of appendix had ruptured and diagnosed with appendicitis: appendectomy. COVID was not tested post vaccination. Course of events was as follows: She had the shot on 29Mar2021 at 12:15, 4 hrs after she felt tired and had sore arm. 7 hours after, her entire intestinal tract and stomach became hard and extended and felt like it was on fire and was extremely painful. 4 hrs later she started vomiting along with diarrhea. The vomiting continued non stop along with the pain and burning in her stomach and back. On 31Mar2021 morning the pain settled into the right lower stomach and became so painful she could barely stand. She went to the ER and was diagnosed with appendicitis. She had surgery that night and found my appendix had ruptured. The OR nurse told he she was the 2nd lady that day who's appendix had ruptured after having their First COVID vaccine and there had been others. She believed this was absolutely the direct result of the vaccine. She queried why were we not warned of this violent side effect of the vaccine. The outcome of events was recovering.

I fainted; blood clots; light headed; I lost all color and my skin was wet and clammy; I lost all color and my skin was wet and clammy; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EN6199, via an unspecified route of administration, administered in right arm on 04Mar2021 15:00 as single dose for Covid-19 immunisation. Medical history included known allergies to Atovaquone/proguanil. Concomitant medications were not reported. On 04Mar2021, approximately 10 minutes post vaccine, the patient fainted in the waiting area. She was told by a witness that she fainted two times. EMTs administered an IV and did a simple EKG. The patient lost all color and her skin was wet and clammy. EMTs were concerned about her heart and transported her to the ER where she had a full EKG and lab work for D-Dimer to consider blood clots. The patient has remained lightheaded for weeks after the vaccine. The outcome of the events was recovered with sequelae.

her MS started to flare; I have a lot of numbness and tingling in my left side; it's still a little tingling; I have a lot of numbness and tingling in my left side; it's still a little tingling; I had 3 days of sheer misery I couldn't use my left side as I am left handed; it made it kind of difficult; I couldn't hold anything in it, if I wanted to put my hand back; I could not even grab my head up to put it off; I have been not feeling that good; shot I went to home I had gastro intestinal problems; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in arm left (reported as "Left shoulder") on 31Mar2021, at the age of 60-year-old (Batch/Lot number was not reported, it was reported that "it says Pfizer and then 8733") as single dose for covid-19 immunisation. Medical history included multiple sclerosis (MS) and she had the GA (gallbladder atony) thing it was awful she mean anything she ate or drank, right to the toilet. Concomitant medications included ibuprofen (ADVIL) taken for an unspecified indication, start and stop date were not reported and Vitamins. Consumer stated, she had the COVID-19 shot last Wednesday 31Mar2021 and she have MS so what it happens was she have got the shot she went to home she had gastro intestinal problems she had she could not get off the toilet for a while and then her MS started to flare, So she have a lot of numbness and tingling in her left side and it's still a little tingling but she had 3 days of sheer misery. She couldn't use her left side as she was left handed so it made it kind of difficult and she live alone. The reporter wanted to know that it was as potential side effects, she was just glad they didn't go full blown affect because they are miserable. When paraphrased the above concern, Consumer stated, No she was starting to get a lot better because she would be really going to say it if it didn't come, because she was not going to stand it but 3 days she couldn't use it at all, she mean she couldn't hold anything in it, if she wanted to put her hand back and probably feel she could not because she was not she could not hold anything she could not even grab her head up to put it off, as she said she had the GA thing it was awful she mean anything she ate or drank, right to the toilet. Consumer stated, No she haven't talked to anybody like any she have been not feeling that good, the first thing she had blown up in because when she had MS it starts to flare she don't she actually want to do is laid down and sleep. For treatment, consumer stated, no treatment, she stayed home, she just rested that's it, it's like her left side is affected her left leg was affected and her arm is affected all the left side is numb and tingly, so she don't like to do anything she don't like to walk anywhere, it's not good. Consumer stated, she just wanted to let us know in case anyone called us with and MS. Date for second shot of COVID-19 Vaccine is "21Apr2021." The outcome of the event "tingling" was recovering; of the other events was unknown. Information about lot/batch number has been requested.

1) Extensive spots, reticular discoloration of the legs, some spots redder than others. In calves of both legs. 2) Sharp breast pain, on the left breast,

Bell's Palsy; right side of mouth felt numb; freezing cold; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6207), via an unspecified route of administration administered in right arm on 01Apr2021 15:15 (at the age of 60-year-old) as SINGLE DOSE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination and was not COVID tested post vaccination. Medical history included high blood pressure. The patient had known allergies with Allegra. Concomitant medications included pravastatin; ascorbic acid, betacarotene, cupric oxide, tocopheryl acetate, zinc oxide (PRESERVISION); cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]); and bupropion. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6199), administered in the left arm on 14Mar2021 at 04:00 PM for COVID-19 immunisation. On 02Apr2021 at 13:00, the patient got freezing cold. The patient was cold for several hours. On 03Apr2021, the patient woke up and right side of mouth felt numb. The patient went to urgent care and was diagnosed with Bell's Palsy on 03Apr2021. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of bell's palsy, freezing cold, and right side of mouth felt numb. The patient had not yet recovered from the events.

possible hearing loss; episodes of elevated tinnitus (pre-existing); vertigo; dizzy; hands felt like vibrating; nauseous; threw up; diarrhea; chills; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 60 years of age), dose 2 via an unspecified route of administration, administered in arm left on 05Apr2021 13:00 (Batch/Lot Number: EP7533) as a single dose for COVID-19 immunisation. Medical history included tinnitus and penicillin allergy, both from an unknown date and unknown if ongoing. Concomitant medications included ciclosporin (RESTASIS) and vitamin d nos (VITAMIN D NOS), both taken for an unspecified indication, start and stop date were not reported. Historical vaccine included PFIZER BIONTECH COVID 19 VACCINE (lot number: EL9629) (at 60 years of age), dose 1 in the left arm on 08Mar2021 13:00 for COVID-19 immunisation. The patient was not pregnant. The patient did not receive any other vaccine in four weeks prior to covid vaccine. The patient had no covid prior to vaccination. The patient has not been covid tested post vaccination. The patient experienced repeated night time episodes of elevated tinnitus (pre-existing), possible hearing loss, vertigo, dizzy, hands felt like vibrating, nauseous, threw up, diarrhea, and chills, all on 05Apr2021 14:00 PM with outcome of recovered/resolved with Sequel. The events resulted to Emergency room/department or urgent care. No treatment received for the events.

Patient had flushing/sweating, rash. Given Benadryl 25 mg PO. Patient stable, released from vaccination site.

This is a spontaneous report from a contactable consumer who reported for herself, a 60-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Ew0158), via an unspecified route of administration, administered in right arm on 08Apr2021 at 16:00 (at the age of 60 years old) at a single dose for COVID-19 immunization. Medical history included overactive immune system, valley fever, Lyme disease, and known allergies to penicillin and morphine. The patient was not pregnant at the time of vaccination. Patient had no COVID prior to vaccination and was not COVID tested post vaccination. Concomitant medications included supplements. Patient had no other vaccines in four weeks. On 09Apr2021, patient experienced very sore arm and vertigo. Then 24 hours later, on 10Apr2021, a feeling of dizziness/severe dizziness and nausea that comes and goes - which has been going on for days. It felt like patient was about to pass out. The patient was not able to stand, she can't stand up. Her body suddenly got hot then followed by feeling chills, but no fever. She was feeling so odd and severe brain fog. The patient was feeling so ill. She tried to call Pfizer because she wanted to know how long this will be going on. She didn't know whether to take the second dose. She felt so sick she couldn't drive or work. The events resulted in doctor or other healthcare professional office/clinic visit. Unspecified treatment was received for the events vertigo, dizziness, nausea, "Not able to stand/can't stand up" and "feeling so ill/feel so sick". The outcome of the events was not recovered.

her whole left side, including the left side of her face went numb; lost focus; throw up; Emotional instability; head hurts; nauseous; Disorientated; Dizzy; Slurred speech; Balance impaired; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2, dose 1 via an unspecified route of administration, administered in left arm on 30Mar2021 17:30 (Lot Number: EW0150; Expiration Date: 31Jul2021) as single dose for COVID-19 immunisation. Medical history included depression from 2005 to an unknown date, blood pressure high in 2020 and unknown if ongoing, and high cholesterol in 2020 and unknown if ongoing; stated she was diagnosed with high blood pressure and high cholesterol about a year ago and was on low doses of blood pressure medication and cholesterol medication. There were no concomitant medications. The patient has no prior vaccinations (within 4 weeks). The patient experienced her whole left side, including the left side of her face went numb on 31Mar2021 with outcome of recovering, lost focus on 11Apr2021 with outcome of not recovered, head hurts on 31Mar2021 with outcome of not recovered, nauseous on 31Mar2021 with outcome of not recovered, disorientated on 31Mar2021 with outcome of unknown, dizzy on 31Mar2021 with outcome of not recovered, slurred speech on 31Mar2021 with outcome of recovered in Apr2021, balance impaired on 31Mar2021 with outcome of not recovered, throw up on 10Apr2021 with outcome of recovered on 10Apr2021, emotional instability on 31Mar2021 with outcome of not recovered. The patient received her 1st dose of the Pfizer COVID19 Vaccine on 30Mar2021 and experienced a bucket load of side effects listed with the vaccine. She mentioned that she has lost focus, her head hurts, and so nauseous. She mentioned that half of her face is numb and that she was hospitalized for 24 hours because the doctors thought she had a stroke. She mentioned she has never had a reaction to anything and the doctors told her that this was related to the vaccine. She is asking how long does this side effect last, if the 2nd dose would have more severe side effects than the first, and could she receive her 2nd dose scheduled this Saturday after experiencing this side effects. She mentioned that her doctors recommended that she get vaccinated. She is in distress as she mentioned that this side effects have affected her life and her job. Further clarified, on 31Mar2021 she was disoriented, dizzy, nauseous, and had a massive headache. She said her symptoms were all on the list of possible COVID-19 Vaccine side effects. She said then her (whole) left side, including the left side of her face went numb. She said she called the nurse on the help line, and the nurse told her to call #. She said she didn't call # because she thought it wasn't necessary. She said she went to urgent care. She clarified at the urgent care they flipped out and wheeled her into a back room and hooked her up to a heart monitor, and brain monitor. She said that was around 5:00PM-6:00PM on 31Mar2021. She said she was taken by ambulance from the urgent care to the hospital emergency room. She said she stayed in the hospital overnight. She said she also had slurred speech, couldn't balance, and couldn't track (clarified as focus). She said it was awful. She said they thought she had a stroke because the left side of her face, and her whole left side were numb. She said if she tried to smile, one side of her face didn't work like other side of her face. She said when she was at the hospital, the hospital did all kinds of tests on her. She said she was told she didn't have a stroke, and her symptoms had to be a side effect of the COVID-19 Vaccine shot. She said the doctors at the hospital told her to "tough it out", and wait until her symptoms were done. She said the numbness was gradually going away on the left side of her body. She said the left side of her face was partially numb, and she had parts of left arm that were still numb. She said Thursday, 08Apr2021, was the first day she felt good. She said she was able to focus, and work. She said she felt she had a steady focus, and was not losing her mind. Friday morning (09Apr2021) was "iffy", but she felt she had improved some during the day. She said by Friday night (09Apr2021), she was dizzy, had a headache, was nauseous, and her balance was off. She said on Saturday morning (10Apr2021), she was nauseous, and started throwing up. She said she continued to throw up until Saturday night (10Apr2021). She said she was still nauseous on Saturday night, but was able to have soda crackers. She said she felt like she was standing at a cliff, because she was still nauseous, but not throwing up. She said Sunday morning (11Apr2021) she was not great. She clarified she was still nauseous, had a headache, was constantly dizzy, and lightheaded. She said she didn't throw up, but her focus kept coming and going. She said she felt worse as Sunday night (11Apr2021) came on. She said today (12Apr2021), she was so nauseous, her head hurts, she was dizzy, and couldn't track (focus) well. She clarified she never had a fever with her other symptoms. Caller asked what the hell was going on, and why was it still happening, and how long were her symptoms going to last. She said she was scheduled to get her second COVID-19 Vaccine shot on Saturday (17Apr2021). Caller asked should she get the second COVID-19 Vaccine shot. Reported also had emotional instability from day one (31Mar2021) of her symptoms. Reported she had been resting for a half hour at a time. She said she would feel better for a period of time after resting, so the resting helped. She said she also took Ibuprofen and Tylenol (clarified as generic (place name withheld) Acetaminophen 500mg). She said the Ibuprofen and Acetaminophen helped to keep her headache in the background. Hospital Treatment: She said while she was at the hospital, she was given Aspirin and Tylenol because of her headache. She said the doctors at the hospital didn't change her home medications. The patient underwent lab tests and procedures which included blood test: normal on 01Apr2021, head CT (computerised tomogram): normal on 31Mar2021, echocardiogram: normal on 01Apr2021, tests: unknown results on an unspecified date (the hospital did all kinds of tests on her), MRI brain (magnetic resonance imaging): normal on 31Mar2021, carotid artery ultrasound: normal on 01Apr2021. Therapeutic measures were taken as a result of head hurts (headache). Reporter seriousness for her whole left side, including the left side of her face went numb: hospitalization from 31Mar2021 to 01Apr2021, required a visit to Emergency Room and Physician Office/Urgent Care.

She had a slow infection in her chest; She was breathing fine, but she got out of breath every now and then; her immune system was not too good; no sleeping; She was so tired; she woke up on Thursday (08Apr2021) sick; She had a cold all year long, but normally doesn't have a color from her chest and nose (mucus). She said she now had a color to her chest and nose mucus; Has had a bad cold after the vaccine and an infection in her lungs; She had no energy, and couldn't work; This is a spontaneous report from a contactable consumer, the patient. This 60 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1, single dose via an unspecified route of administration in the left arm on 07Apr2021 around 12:15 (at the age of 60 years-old) for COVID-19 vaccination. Medical history included smoker since 1976 pack-a-day of cigarettes since 16, quit for 11 months, she went back to smoking, x-rays done in the 1990's and the patient was told that the lower part of her lungs were flat and was told she had chronic obstructive pulmonary disease (COPD) and emphysema at that time. She said her lungs were pretty bad. Family Medical History Relevant to adverse events were not provided. Concomitant medications included ascorbic acid, rosa canna fruit (VITAMIN C PLUS NATURAL ROSE HIPS) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient had a slow infection in her chest on an unspecified date (also reported as her doctor told her she had a little bit of an infection), a bad cold after the vaccine and an infection in her lungs on Apr2021, she woke up on Thursday 08Apr2021 sick, was so tired on 08Apr2021, had no energy and slept for 5 hours, couldn't work on Apr2021, had a cold all year long, but normally clear drainage from her chest and nose, she now had a color to her chest and nose mucus on Apr2021, she was breathing fine, but she got out of breath every now and then on an unspecified date and her immune system was not too good on an unspecified date. She reported that on 11Apr2021 to 13Ap2021 she has been fine, no sleeping. The patient had been told by her doctors that her immune system was not too good, and she should quit smoking. She said her sister was a licensed practical nurse (LPN), and her sister told her that she thought she (the reporter) may have had a cold when she got her first COVID-19 Vaccine. She said she had felt good since Sunday (12Apr2021). She said she felt stronger, but her cold was not better. She said she was breathing fine, but she got out of breath every now and then. The patient reported that she would get a lung infection if she had a bad cold. She said her doctor told her she took way too many antibiotics in the past, and now her body was used to the antibiotics It was also reported that she said she doesn't take antibiotics. She reported that her second COVID-19 Vaccine dose was scheduled for 05May2021, which was 4 weeks after the first COVID-19 Vaccine dose. There were no relevant laboratory tests done. There were no emergency room (ER) or physician office visits. Nature Made Vitamin C 1000mg yesterday (12Apr2021). She said she was taking 1 Nature Made Vitamin C (Lot Number: 2370401, Expiration Date: Feb2024) 1000mg a day. Adverse events following prior vaccinations were not applicable. The clinical outcome of no sleep, chest infection, no energy, couldn't work, out of breath, immune system was not too good was unknown, not recovered for cold, sick, color to her chest and nose mucus and recovering for tired. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

thought she was having a stroke; severe cramp in her left leg below the knee to her toes and it is extremely painful; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in the right arm on 09Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included ongoing blood pressure high diagnosed about 7-8 years ago. The patient's concomitant medications were not reported. The patient got her first dose of the Pfizer Covid vaccine on 09Apr2021. On Saturday, 10Apr2021, she got this severe cramp in her left leg below the knee to her toes and it is extremely painful and thought she was having stroke. She stated that she was treating with a warm cloth and was going to go to the emergency room; rubbing down in case there is a blood clot. She wanted to know if this could be from the vaccine. The outcome of the events was not recovered. Information on the lot/batch number has been requested.

Anaphylactic reaction; it started like a flushed feeling; She felt woozy; she still feels a little tight in her throat/she does feel tight, scratchy, and hoarse; she still feels a little tight in her throat/she does feel tight, scratchy, and hoarse; she still feels a little tight in her throat/she does feel tight, scratchy, and hoarse; she is just a little uncomfortable, just a little today, not too bad; She adds that she is having a hard time focusing; This is a spontaneous report from a contactable consumer (patient). This 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8731 and expiry date unknown, Solution for injection), via an unknown route on 12Apr2021 at 15:05 (at the age of 60-years-old) at single dose on left arm for COVID-19 immunization. Relevant medical history included allergies, asthma, she had anaphylaxis in the past to allergies. (Unspecified allergens). The patient added that she had issues for about a year before her surgeon had to do a surgery on her throat. She added she was fortunate because her thyroid was in her airways 14 years ago and her body exploded with allergies and her throat closed a lot. When the doctor did the surgery, the doctor opened her throat up more so that if she had another anaphylaxis it would not result in death. Concomitant medications was not reported. On the same date, after the vaccination the patient had anaphylactic reaction. She stated that happened 62 minutes, it might have been 64 minutes and also stated a few minutes after 60 minutes. The vaccination facility released her after 30 minutes at 15:35 and when she realized something was happening it was 16:10 when the patient realized what it was that she was experiencing. The vaccine facility held onto her for 30 minutes, so she got the vaccine around 15:05 and they watched her for 30 minutes. She believed it was around 65 minutes later that she started noticing something was happening. The patient started like a flushed feeling. She does not know to describe it, it was like she had a drink or something like she felt flush or something over her system like a wave or something. It was like a strong drink or something. She does not drink a lot but it was like woohooo, a wave of something, and then she felt woozy. It was not too bad at first, she was at a bank drive through and she was not driving. The patient was going to pick something up so she stopped for 5 to 10 minutes. She was on the phone with a friend. She felt woozy. The patient asked her husband to buy diphenhydramine (Benadryl). Her husband called back when she got done at the bank, and she was only 10 minutes from her house. The patient had her EpiPen with her. The patient was feeling better and she still feels a little tight in her throat and the way she explained it yesterday was that it was like someone had their finger down her throat, it was uncomfortable. She was just a little uncomfortable, just a little today, not too bad. She added that she was having a hard time focusing. Today, the patient felt tight, scratchy, and hoarse. It was not like it was last night. The patient did not receive any treatment for the events. Outcome of the events were unknown. Description of Product Complaint: Description of complaint: Consumer reporting an AE for the Pfizer COVID 19 vaccine mentions that they told her not to take the flu vaccine because she would get sick. Her flu symptoms would go on for 2-3 months. If she got the flu shot in September or October, she would not feel well through Christmas. Caller adds that she never got the flu again when she stopped the vaccine. Caller does not know manufacturer, NDC, lot or expiration date for the flu vaccine she had that made her sick Caller does not have any information about the Benadryl - and she does not have the bottle that she took that made her sleepy because she added that the only bottle she had was the one that her husband bought yesterday and it was not opened and she had not taken it. Caller added that she had not taken Benadryl in 14 years since before her surgery. Caller adds it might have been 15 years, she would have to remember that. AE identified after call completed. No NDC, lot or expiration date provided for Benadryl caller took 14 to 15 years ago. Follow-up attempts completed. No further information is expected.

Back disorder; lower back issues; Feeling abnormal; felt fuzzy; Vaccination site pain; sore arm; Dizzy; Fatigue; Energy decreased; not feeling as much energy as before; Pain upon movement; walk about a block but then starts to hurt; This is a solicited report from a contactable consumer (patient) via a non-Pfizer sponsored program, based on the information received by Pfizer (Manufacturer Control No: 21K-163-3774842-00). Solicited report from a consumer of a 60 year old female with events of heart/atrial flutter, atrial fibrillation, eye surgery and arm surgery and non-serious weight gain due to attempting to stop smoking, lower back issues, felt fuzzy, got first dosage of covid-19 vaccine and experienced sore arm, fatigue and dizzy from the blood thinners after surgery, still not feeling as much energy as before and walk about a block but then starts to hurt with humira 40mg/0.4ml (adalimumab). The patient had a relevant medical history of tobacco use/four cigarette sticks per day, seropositive high titer rheumatoid arthritis, fingers swelling, joint pain, joint swelling and lost of blood flow in hands and legs. On unknown dates, the patient experienced eye surgery, arm surgery, lower back issues, felt fuzzy, got first dosage of covid-19 vaccine and experienced sore arm, fatigue and dizzy from the blood thinners after surgery, still not feeling as much energy as before and walk about a block but then starts to hurt. In 2020, the patient experienced heart/atrial flutter and atrial fibrillation. In Sep2020, the patient experienced weight gain due to attempting to stop smoking. On 24Feb2021, the heart/atrial flutter and atrial fibrillation resolved. Covid-19 vaccine was also considered suspect. The patient had eye and arm surgery in the past. On 24Feb2021, she underwent pulmonary vein cryoballoon ablation surgery for the atrial fibrillation and atrial flutter. She had a procedure done and went into her heart and froze the nerve endings that were causing the atrial fibrillation, and also fixed the flutter in her heart. The causality as per reporter for this procedure was reported as no reasonable possibility. She still recovering. She discontinued the Humira two weeks before the surgery and took her last injection on 10Feb2021 and was paused it for four weeks, but she started back it on 10Mar2021. She follows up with her surgeon at the end of the month and she hopes this helps got her off of the blood thinners and other medicines, she been on for this. She stated that this was not related Humira. She was advised by her physician to increase the exercise to lose some weight. With her lower back issues, she was hoping that when she got off of the blood thinners, she could do pain shots again and start exercise. She could walk about a block but then she started to hurt. She had been careful with her diet also, cut out the salt also. This had nothing to do with Humira and she did not want to be contacted about this again for this also. She felt fuzzy, it took her most of the morning to get woken up. Her Doctor thinks once she would off of the blood thinners she would be back to normal. Other than that she feels fine. She does not wanted to be contacted about this. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown date, patient received first dose COVID-19 Vaccine manufactured by Pfizer, lot number unknown. She agreed to have physician contacted. Blood thinner was also considered as co-suspect. Other medical history included abstains from alcohol, contrast dyes allergy manifested by scratch throat, allergy manifested by bowel movements (oral medications for rheumatoid arthritis; up to eight times a day and slept 15 hours per), prevent esophagus damage, heart, low thyroid, and attention-deficit/hyperactivity disorder. The patient's concomitant medications included pantoprazole to prevent esophagus damage, metoprolol for heart, levothyroxine for low thyroid, vortioxetine hydrobromide (TRINTELLIX) for depression, and dexamfetamine sulfate (DEXTROAMPHETAMINE) for attention-deficit/hyperactivity disorder. The patient underwent laboratory tests and procedures which included blood work: everything was fine in Jan2021; chemical stress test and treadmill stress test: confirmed atrial fibrillation and atrial flutter in Sep2020; body weight: gain in Sep2020; and X-ray: confirmed atrial fibrillation in Sep2020. The action taken in response to the events for adalimumab and apixaban was unknown. The patient recovered from atrial flutter and atrial fibrillation on 24Feb2021. Outcome of Feeling abnormal and Pain upon movement was unknown. The patient had not recovered from the remaining events. Change History: On 05Mar2021, received updates to patient demographics, medical history, event information, reporter opinion of causality, suspect drug information, concomitant drug information, past drug information, laboratory/diagnostic procedures and narrative description. The events of "atrial flutter", "atrial fibrillation" and "weight gain due to attempting to stop smoking" were added. On 11Mar2021, received updates to patient demographics, medical history, event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information, laboratory/diagnostic procedures and narrative description. The events of "LOWER BACK ISSUES" and "WALK ABOUT A BLOCK BUT THEN STARTS TO HURT" were added. the event of "atrial flutter" was amended to "heart/atrial flutter". On 08Apr2021, received updates to event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information and narrative description. The events of "felt fuzzy", "got first dosage of covid-19 vaccine and experienced sore arm", "fatigue and dizzy from the blood thinners after surgery" and "still not feeling as much energy as before" were added. Causality for humira 40mg/0.4ml(adalimumab): The reporter's causality for the event(s) of heart/atrial flutter, atrial fibrillation, eye surgery, arm surgery, weight gain due to attempting to stop smoking, lower back issues, got first dosage of covid-19 vaccine and experienced sore arm, fatigue and dizzy from the blood THINNERS after surgery unknown onset and fatigue and dizzy from the blood thinners after surgery unknown onset with humira 40mg/0.4ml(adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of felt fuzzy, still not feeling as much energy as before and walk about a block but then starts to hurt was not provided. Manufacturer opinion is that there is no reasonable possibility that the events of heart/atrial flutter, atrial fibrillation, eye surgery, arm surgery, weight gain due to attempting to stop smoking, lower back issues, felt fuzzy, got first dosage of covid-19 vaccine and experienced sore arm, fatigue and dizzy from the blood thinners after surgery unknown onset, fatigue and dizzy from the blood thinners after surgery unknown onset, still not feeling as much energy as before and walk about a block but then starts to hurt are related to humira 40mg/0.4ml(adalimumab). The reporter's assessment of the causal relationship of the events with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information , the events of sore arm, fatigue and dizzy could be related to the suspected drug of BNT162B2. The other events are most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Bell's Palsy; I started to have sharp pain behind my ear; sinus congestion; deep sore throat; dry left eye; This is a spontaneous report from a contactable other healthcare professional (HCP; patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 27Mar2021 at 16:00 (Lot Number: ER8733, expiry date not reported) at the age of 60-years-old at a single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The vaccination facility type was facility. The patient received no other vaccine in four weeks. The patient had no COVID prior to vaccination and was not tested for COVID post vaccination. Medical history included penicillin-rash; high cholesterol being treated with Repatha; slightly high blood pressure being treated with lisinopril; cysts in pancreas, thyroid and kidneys-all benign. Concomitant medications included evolocumab (REPATHA) for high cholesterol; lisinopril for slightly high blood pressure; spironolactone for an unspecified indication and testosterone for an unspecified indication, all start and stop dates were not reported. The patient received the first dose of the Pfizer-BioNtech Covid-19 vaccine on 27Mar2021, 4 days later on 31Mar2021 20:30 she developed Bell's Palsy. She would like to know if in the clinical trials those who experienced this adverse event was after the first or the second dose of the vaccine. She already reported this adverse event to Safety, online and verbally. She would like to know if Pfizer recommends for people who develops Bell's Palsy after the first dose of the vaccine not to receive the second dose and if there's information about the cases of Bell's Palsy after receiving the vaccine during the vaccination to larger populations. She's also wondering if there is information about how long it takes to resolve. Patient reported that four days after vaccination on 31Mar2021 at 20:30, she started to have sharp pain behind her ear, sinus congestion, deep sore throat, and dry left eye, went to bed, next morning she woke up with Bell's palsy on left side of face (also reported to have occurred on 31Mar2021 20:30). These resulted in a doctor or other healthcare professional office/clinic visit. The patient was treated with high dose prednisone and Valtrex. The outcome of the events was not recovered.; Sender's Comments: Bell's palsy is not uncommon in general population, however the causal association between bell's palsy and the usage of the vaccine BNT162B2 cannot be excluded because of strong temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Caller states the patient had an anaphylactic reaction twice that caused her to go to the emergency room; couldn't swallow; right side of the patient's face swelled up and her lips were numb; right side of the patient's face swelled up and her lips were numb; face numb; hands itching; tongue had swelled up; voice was scratchy; This is a spontaneous report from a contactable consumer, Reporter's sister via Pfizer-sponsored. A 60-year-old female patient received the second dose of BNT162b2 (Pfizer-Biontech COVID-19 vaccine, Solution for injection, Lot number: unknown, NDC number: Unknown, Ex-piry Date: Unknown) via an unspecified route of administration on 01Mar2021 on an unknown ana-tomical location as a single dose for COVID-19 immunization. Caller provided that her sister got the vaccine for COVID Prevention and because the patient has a handicapped, bedridden husband who has MS and is immune compromised, and it was to help prevent him from getting sick. Caller reported that the patient received the product during the daytime, all the women at the patient's job, which was home health payroll, everyone left to get the vaccine during work hours, like in the AM at around lunch time. Patient's medical history and concomitant medications were unknown. Patient has not received any prior vaccinations within 4 weeks. Patient had no other vaccines on the same day as the suspect product. Patient received first dose of BNT162b2 (Pfizer-Biontech COVID-19 vaccine, Solution for injection, Lot number: unknown, NDC number: Unknown, Expiry Date: Unknown) on 08Feb2021 with no reaction. She worked for a health agency and the whole office went and got it. Caller provided that her sister had a reaction the first time, on 03Apr2021, where her sister woke up with itching started in her hands and ended up migrating to her whole body. By morning patient's tongue had swelled up, couldn't swallow and her voice was scratchy, like the caller couldn't understand her sister's speech well. Caller provided that her sister went to the ER and said there was a whole team giving her urgent care, medication, and such. Caller reported that her sister said the ER didn't find anything in her bloodwork, and the caller did not think the patient was being treated for any other medical conditions, and caller did not think her sister is on any medications, but caller said to not quote her on that. Caller knew her sister had a weight problem, but she did not know if her sister needed blood pressure medication or anything. Caller reported her sister said that the bloodwork from the ER did not find any-thing, and the patient was not admitted to the hospital. Caller reported that at this time, her sister's adverse events were no longer ongoing as her sister was given Steroids, like Prednisone, Benadryl and Famotidine, and she took those products as recommended by the doctor. Caller did not know the end date of her sister's events; all she knew was that the reaction initially started on 03Apr2021. Caller stated that her sister was allergic to nothing, and she has never had incidences of itching like that, where the itching was so bad that she was stripping down and the patient's daughter was patting the patient down with witch hazel. Caller stated that ER released the patient and gave her some medications and such. Caller stated that a day or so later, there was a second round of reaction: the right side of the patient's face swelled up and numb and her lips were numb, like when people have a dental procedure. Lips were numb for a while. Upon completion of the medications she was given, the reactions stopped. Patient regularly saw the family doctor. She would go back to see her Doctor on Thursday. HCP Information was unknown to the caller, but caller stated that her sister had been recommended to go to her PCP and get an Epi Pen. Caller stated that knock on wood, so far, her sister was holding her own, and it had not happened again. Caller stated that she was reporting the data that her sister gave to her after having the Pfizer vaccination. Caller stated the patient had an anaphylactic reaction twice that caused her to go to the emergency room. No relevant tests were done. Caller stated that she had the dates that she had her shots and where she had her shot at. Caller stated somebody called and reported it already. Caller stated she was trying to press three but never could figure out which prompts was. Caller stated they said if she called this number, they would tell her at the medical information department if this occurrence has happened to other people, like statistics. Caller stated they tried to call this number, but it was too long of a wait. Caller stated that she did not have the vaccination card, she never asked for them. Caller does not have card with her at time of call for LOT, NDC, Expiry date. Caller stated that she knew that all the COVID vaccines are just in the Emergency Use Authorization stage and in clinical trials, but caller really thought that all manufacturers should be advertising that they would like feedback from patients. Caller has not heard anything from any of the manufacturers saying that people are welcome to reach out and report side effects. Caller states that she only knew to call because she used to be a Home Health Worker, and she thought this is an important data. Caller has never seen on any of her 19 TV channels about calling to report. Caller stated that the girl who first answered her call, read a clinical data sheet about joint pain being seen in 23% of patient's and not knowing a percentage for anaphylactic reactions, caller was wondering if this was true. Caller verified that she just wanted to ask basically that patient was not alone, if other people might have had that happen too. Caller stated that she tried to call, and it would ask another question and it would say press 1 or 2, then it would ask other questions and it would say press 1 or 2, she never got an option 3. Caller asked: how much percentage, has anyone reported this side effects weeks after the second dose. Caller was wondering if this reaction could have been from the vaccine. Investigation Assessment: No. The outcome of the events were unknown. Information on the lot/batch number has been requested.

anaphylactic reaction; anti kell antibodies in her blood; nausea; her left and her right hips, both, had severe pain/her right knee joint is in severe pain; she could barely walk and she couldn't bend at all; really weak; had leg aches; she couldn't stay awake/she couldn't sleep again; diarrhea; severe pain at the back of her neck with a headache; severe pain at the back of her neck with a headache; had extreme fatigue; lightheadedness; upper back pain; bloody nose; she couldn't see out of her left eye for about 2 hours; she couldn't breathe; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8731), via an unspecified route of administration, administered in Arm Right on 08Apr2021 10:41 as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 60 years). Medical history included ongoing chronic obstructive pulmonary disease, ongoing chronic kidney disease and Positive ANA. The patient's concomitant medications were not reported. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8727) on 18Mar2021 for covid-19 immunisation and experienced First dose: a little bit of soreness and swelling all on the site. The patient stated that during her second dose last Thursday on 08Apr2021, she had an anaphylactic reaction and she couldn't breathe and long story short she had to go to the emergency room and she was given all kinds of epi shots and treatment and stuff and eventually she had to be kept in the ICU unit. She is not sure why she had such a severe reaction. She wanted to report that since then she has kept track every day on how she has been and she actually thought yesterday was the first day that she had felt better. She had extreme fatigue, lightheadedness, upper back pain and even a bloody nose on 10Apr2021 and also she couldn't see out of her left eye for about 2 hours. Then on 11Apr2021, she had severe pain at the back of her neck with a headache that lasted about 20 minutes and she couldn't move her neck. She had diarrhea and the only temperature she had was on 12Apr2021, it was only 99.5 degrees Fahrenheit, which isn't bad, but she had really bad diarrhea on 12Apr2021 and she took Imodium. She had a headache and slight breathing difficulties and things like that. On 13Apr2021 she had a headache, was really weak, had leg aches, fatigue that was really bad and she couldn't stay awake and her temperature that day was 98.7 degrees Fahrenheit which is normal. Then yesterday, 15Apr2021, she thought she was over all the things and that she was feeling better from the fatigue, nausea (occurred on an unspecified date), lightheadedness but she couldn't sleep again. She didn't sleep since Wednesday morning until last night finally and she only slept for an hour since Wednesday morning. She woke up on 15Apr2021 and had no symptoms except her left and her right hips, both, had severe pain and she could barely walk and she couldn't bend at all. All she could do it take Tylenol and she used a heating pad and the pain was excruciating. She went to bed last night and she did sleep for maybe a total of 2 hours and when she woke up this morning her left hip seemed to be a little better but her right hip is still in severe pain and now her right knee joint is in severe pain too. Other than that, she has no other symptoms just the joint pain. She didn't know it would go on for this long, it has been over a week now and she just wanted to let us know about this. The patient was hospitalized for the event anaphylactic reaction from 08Apr2021 to 08Apr2021. The patient underwent lab tests and procedures which included Blood typing: anti kell antibodies (doctor randomly decided to do a blood typing and they found anti kell antibodies in her blood) on an unspecified date, temperature: 99.5 degrees fahrenheit on 12Apr2021, temperature: 98.7 degrees fahrenheit on 13Apr2021. Therapeutic measures were taken as a result of anaphylactic reaction, dyspnoea, diarrhea and arthralgia. Outcome of the event anaphylactic reaction was recovered with sequelae on 09Apr2021 while outcome of the events nausea, dyspnea, arthralgia, sleep disorder and movement disorder was unknown. Outcome of the event vision impairment was recovered on 10Apr2021 while outcome of the event neck pain was recovered on 11Apr2021. Outcome of the remaining events was recovered on 15Apr2021.

blood pressure (BP) went over 269/149, it made my blood pressure go up.; left side of middle back had some excruciating pain; Nauseous; I had a major body ache; it started hurting the minute she put it in my arm/Excruciating pain; pain in the neck down the arm; I had a major body ache; it started hurting the minute she put it in my arm/Excruciating pain; pain in the neck down the arm; I had a major body ache; it started hurting the minute she put it in my arm/Excruciating pain; pain in the neck down the arm; I got a mark on my arm, my arm started swelling; This is a spontaneous report from a contactable consumer reporting for herself. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EW0164/expiration date: 30Jun2021), via an unspecified route of administration, on 16Mar2021 (at the age of 60 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EN6208/expiration date: not provided), via an unspecified route of administration, on 16Mar2021 (at the age of 60 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION and experienced a headache. Relevant ongoing medical history included Diabetes Type II from about 5 years ago in 2016, fibromyalgia diagnosed about 6 years ago in 2015, and high blood pressure. Concomitant medication included gabapentin from an unspecified date at 600mg 3x/day for fibromyalgia, empagliflozin (JARDIANCE) from an unspecified date at 10mg 1x/day for Diabetes Type II, clonidine from an unspecified date at 30 mg, 2x/day for high blood pressure and labetalol from an unspecified date at 200 mg, 2x/day for high blood pressure. On an unspecified date in Mar2021, the patient experienced her blood pressure (BP) went over 269/149, it made my blood pressure go up, which required hospitalization overnight. Also on an unspecified date in Mar2021, the patient experienced a mark on her arm, and her arm started swelling. On 16Mar2021, the patient experienced major body ache, described as it started hurting the minute she put it in her arm, excruciating pain and pain in the neck down the arm, and she was nauseous. She described that she couldn't get out of the bed because of so much body pain. On 21Mar2021, the patient experienced her left side of middle back had some excruciating pain. The clinical course was as follows: I had a major body ache with the second vaccine. I did not have any problem except the headache with the first one but I took second one on this past Friday, I got very nauseous, it started hurting the minute she put it in my arm, which is on the left side. I got a mark on my arm, my arm started swelling. Saturday morning I couldn't get out of the bed because of so much body pain, Sunday my left side my middle back I had some excruciating pain I rushed to the doctor to the ER, my BP went over 269/149 and they had to give me pain medicine and BP medicine to reduce the blood pressure. I made it to the doctor and I'm getting medicine for the pain. I woke up in the morning there's pain in the neck down the arm and it's aching, the side I got the shot, the side is hurting, excruciating pain in my arm. I had to go to the ER straight to my doctor's office, they wouldn't let me drive or anything straight to the ER where they administered 2 doses of pain medicine and 3 doses of blood pressure, the pain was so intensive it made my blood pressure go up, the doctor said all of this was coming from the vaccine." Relevant lab data on an unspecified date in Mar2019 included blood pressure 269/149. The patient received treatment for the events blood pressure high, body pain, neck pain, pain in arm, and back pain. The outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021446955 same reporter/patient/drug, different event in separate dose

Itching on her hands and her feet; Chills; Clammy; Sensitivity to light; inflammation; Under her eyes it is swollen; She was having severe diarrhea; having severe dry heaves; vomiting bile; It had dehydrated her/lead to dehydration; Her throat closing up and it being sore from vomiting and dry heaving; couldn't swallow to get any fluids in; Her throat closing up and it being sore from vomiting and dry heaving; she was struggling with having a dry mouth; puffiness; Headache; severe muscles aches/Muscles pain; feeling nauseous; Was a little warm on her arms/ it was warm to the touch; it just looked like a bee sting and it wasn't super sore; sensitive to the touch; It had big red spots; had a little tiredness; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 16Apr2021 at 10:00 (at age of 60 years old, Lot Number: EW0ISO) as single dose for covid-19 immunization. Medical history included she had lupus, sjogren's syndrome. The patient's concomitant medications not reported. The patient previously took Pneumonia Vaccine on 04Mar2021 (Anatomical Location: Left arm); took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 26Mar2021 at 10:00 (at age of 60 years old, Lot Number: the lot number starts with ER something and then it ends with a 3) as single dose for covid-19 immunization; took azathioprine for lupus and had allergic reaction; took belimumab (BENLYSTA), subcutaneous from an unspecified date (Lot Number: PV7G; Expiration Date: Jun2023, NDC: 49401-088-01, Number on the side: 0147098) to an unspecified date, self injection once a week for lupus. She gets it through the VA and it is subcutaneous use and the manufacturer is company. she was immunocompromise, she had lupus, so she was off of her medication (BENLYSTA) for a month per the CDC guidelines. She wanted to let Pfizer know that as well. For her first COVID vaccine she was originally scheduled to go 6 to 7 days after she had her pneumonia shot and they told her that she would have to wait 2 weeks before having her COVID shot and she did. Other than that she had followed the guidelines and she had been able to take her regular medications but she had to stop her Benlysta because of her immune system and everything. She had been following through on what the CDC has said. Patient stated that she just did a follow up with her doctor because of what happened after her second Pfizer COVID vaccine and her doctor recommended her to let Pfizer know about the side effects that she was having. On Friday 16Apr2021 she had her shot at 10 AM and it was no big deal, it was a little warm on her arms. She stated that it just looked like a bee sting and it wasn't super sore, it was warm to the touch and sensitive to the touch. It had big red spots and there has really been no change since it began. It looks about the size of a bee sting and it was still there. She had a little tiredness and she was not hungry but when she woke up at 06:40 the next morning (17Apr2021) on Saturday she was having severe dry heaves and vomiting bile and she could not get it under control. It had dehydrated her and she was having severe muscles aches. She had the severe dry heaves and the vomiting that lead to dehydration and then she went to the emergency room and she got replenished and they had given her something for feeling nauseous and eventually she was released 3 to 4 hours later. They gave her pills as well so she was doing well now and she hasn't done anything since she went to the emergency room with the vomiting and feeling nauseous. She went there about 1030 to 1040. Before she went she couldn't stop and she told herself that if it didn't stop on the 5th time then she was going to go to the emergency room and it got really bad so she had to call 911 to come and get her. Then she was having severe diarrhea on Sunday (18Apr2021) and the only way she could stop that was for her husband to pick up antidiarrheal pills. That only went away because of the medicine from the pharmacy. She had the over the counter medicine and she took Imodium. She hasn't been eating a lot so she hasn't had a bowel movement since she took that medication. When she had diarrhea there was no substance, it was very watery. And now today (unspecified date) she was having another reaction that she was seeing and it was just itching on her hands and her feet. She had been continuing to take the Benadryl and something that they gave her in the emergency room and she had taken Tylenol for the little headache that she has had. She had a slight headache and she was still taking Tylenol like they had recommended. This began the same time as she was vomiting on 17Apr2021 when she was going through all of that she had the slight headache. But her biggest concern was during this time when initially on Saturday (17Apr2021), her throat closing up and it being sore from vomiting and dry heaving, she was having the dry heaves her airway closed shut and she couldn't swallow to get any fluids in. Her concern was that the back of her throat was killing her and it was totally closed up so she had to go to the emergency room. She had recognized this because in the past she has had a medication where she had an allergic reaction (she thinks it is the medication that they gave her for lupus because she has been on several different things. She thinks azathioprine but she can't recall exactly but she thinks that might of been the one that did it to her) and it had closed her esophagus up the same way like this. This time it got worse to where she couldn't even swallow water no less a pill. This was on 17Apr2021. When she went to the emergency room they gave her the hydrocortisone to take it down and she actually had felt better while she was waiting for the saline drop. She was able to swallow when her airway was opened again by the time they treated it with the hydrocortisone. Around 16:00 she was better when she left the emergency room that same day 17Apr2021. She doesn't really have a sore throat, it is pretty fine. It seems to be okay she thinks that once the dry heaves and all that stopped it helped to relax that. She was a little raspy from the whole thing and she was struggling with having a dry mouth but that even had been resolved as far as her throat. She had no other reactions than what she explain but she also had a lot of muscles pain but that was to be excepted because it says that on all that she has read. She had had all of the reactions listed except for fever. She had had chills and then when clammy and then was clammy and had chills. She had all of those side effects listed on the sheet and when she went on Saturday following her vaccine to the emergency room most of the side effects were treated in emergency room. They gave her Pepcid, hydrocortisone through her IV and gave her Zofran for the vomiting and they said to keep taking acetaminophen. They gave her cetirizine for allergy or the itching or whatever and they also gave her famotidine which she thinks is Pepcid. Since being off the lupus drug she was getting her symptoms again such as sensitivity to light, inflammation and the dry heaves didn't help so under her eyes it was swollen and she just takes it as it was because she was not on her medication and she had something else injected inside of her. Also, she had Sjogren's disease too so her eyes were already drier than normal and she had had puffiness since 17Apr2021 when she was vomiting. She just wanted to make sure that Pfizer got that information because she didn t see that listed. The only side effect she was related was the swollen glands and she has glands in her throat but she wanted to be sure that Pfizer had that data just in case if it could help someone else. Again, she wants to reiterate that with her first dosage she had no problems. She couldn t even see the mark and all of this is stemming from the second dose of the COVID vaccine. The outcome of the events "Dry heaves, Bilious vomiting, Dehydration, Her throat closing up and it being sore from vomiting and dry heaving, Unable to swallow, Dry mouth, Nauseous" was recovered on 17Apr2021. The outcome of events "Feeling of warmth, Vaccination site pain, Hyperaesthesia, Vaccination site erythema, Tiredness" not recovered. The outcome of the event "Headache" was recovering. The outcome of other events was unknown. No follow up attempts are needed. No further information is expected.

My throat was itchy/my throat felt worse; My throat was itchy in between that half hour my voice started to change; my throat felt worse; I have wheezing in my lungs; I am allergic to them/ Severe reactions and had to be hospitalized overnight; had problem swallowing a little bit and voice changes after talking; This is a spontaneous report from a contactable consumer. A 60-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number and expiration date were not reported), via an unspecified route of administration, administered in Arm Left on 15Mar2021 (Age at Vaccination 60 year), as single dose for covid-19 immunisation. Medical history of the patient included anxiety, depression, nerve pain, ongoing blood pressure (hypertension), change in personality and cardiac disorder. Concomitant medication of the patient included levothyroxine, atorvastatin calcium (cholestat [atorvastatin calcium]), pantoprazole, 1300mg fluconazole (Fluxizol), 81mg aspirin, lubiprostone (Amitiza), alpha lipoic acid, baclofen, linezolid (Zenix [linezolid]), centrum silver, 10mg rosuvastatin calcium (Crestor), 100mg docusate sodium (stool softener), amlodipine and magnesium oxide for blood pressure. Patient was on Benazepril HCTZ for heart, Pristiq for anxiety or depression, citalopram for pain (something to do with pain I can't remember), Effexor for Anxiety, Lexapro, Levaquin, and Sulfa for rashes. Patient got it from her bladder infection. Cyclobenzaprine (I can't remember), Gabapentin, change in personality and nerve pain. Metoprolol for heart. Patient was not taking any of these medications now she got several allergies from them. Patient had a lot of allergies. She was on lot of medications. But it was not what she was taking any these medications on the same, so she was like what was going on. Patient not taking the medication (Unspecified Medication), she was allergic to them, but she was taking other medication. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number, PF12ER6200), via an unspecified route of administration, administered in Arm Left on 22Feb2021 (Age at Vaccination 60 year), as single dose for covid-19 immunisation. On 15Mar2021, the patient had severe reactions and had to be hospitalized overnight. Within mild reaction for 15 minutes and within 40 minutes severe. Patient went to have it done at the hospital they walked her down to the ER they get to give her an epi Pen injection into IV." When again probed for the concern, Patient stated, she had it done at the hospital, they after 15 minutes her throat was itchy they may say another half hour in between that half hour her voice started to change and her throat felt worse they walk her down to the ER her throat was hurting then slowly they gave her Epi Pen and they injected in an IV with steroids. Patient had wheezing in her lungs and she spent the night in hospital for observation. Patient stated that she still had problem swallowing a little bit and voice changes after talking. Patient wanted to know it was like how she supposed to find out what she was allergic. Patient further stated, "Because she want to you know she need an update how was it bad so she want to had to go all this what she was allergic. Event outcome for the events swallowing difficult and for voice alteration it was not recovered and for other events it was unknown. Information about lot/batch number has been requested.

About 5 minutes after injection: fast growing wave of internal burning sensation throughout body, feeling that I would pass out, lightheafdedness, increased heart rate and blood pressure, mild difficulty with speech/thought/concentration, freezing hands, wabbly/shaky., chest tightness, very slight throat soft tissue sensation

Lips and left side of face numbness and tingling about 10 minutes after first dose of Pfizer COVID-19 vaccination. Started first on the lips and then spread to left side of face and continued for 45 minutes to an hour after vaccination.

Headache; muscle aches and pains; feels like she is getting a fever; thinks she is having the chills; feeling a little warm/ She is cold, too; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) intramuscular on left arm, near the top (in the muscle), at single dose for vaccination on 29Dec2020 at 12:45 pm at 61-year-old. Medical history included: hay fever allergies, allergic to prochlorperazine maleate (COMPAZINE). Concomitant medication was not reported. No additional vaccines administered on same date of the Pfizer vaccine. On 30Dec2020, the patient stated her headache started about an hour and a half ago. She started having the muscle aches and pains when she woke up this morning. She felt like she was getting a fever, but she was at work and couldn't take her temperature. She was feeling a little warm, she was cold, too. She was having the chills. The patient confirmed all of these symptoms just started happening this morning (30Dec2020). No emergency room nor physician office visited. No relevant tests. Action taken for BNT162B2 was not applicable. Outcome of the events was not resolved. It was reported as non-serious.

Received COVID vaccine, severe headache started 5 minutes after the administration. Jittery, nauseated. Continued to have worsening symptoms. Nausea/Vomiting, muscle twitching, severe headache, increased heart rate went to ED on 1/5 at 0100.

aches/pains/body aches and pains; hot flashes; a little fever/fever of a little over 100; she was freezing/chills; cold was worse; couldn't get comfortable; started feeling bad when she went to bed; This is a spontaneous report from a contactable consumer (patient's husband). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EH9899), via an unspecified route of administration on 27Dec2020 at 12:45 on Left Upper Arm at single dose for COVID-19 immunization in hospital. No additional vaccines administered on same date of bnt162b2. The patient medical history included she may be a little overweight, but she was not obese. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), levothyroxine sodium (SYNTHROID), lubiprostone (AMITIZA) for stomach. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously had the flu shot (influenza vaccine) in the past for immunization and got sick once afterward, she was not sure if it was food poisoning or the flu vaccine, she didn't get one this year. Patient's husband reported that patient got the vaccine yesterday (27Dec2020). She felt fine all day but started feeling bad when she went to bed on 27Dec2020. She was experiencing aches, pains hot flashes and a little fever a little over 100. She had a miserable night. She had body aches and pains, hot flashes and a little fever started around one in the morning of 28Dec2020. The fever was a little over one hundred. It looked like she what she got was normal side effects. The reporter didn't know how long approximately and how high her fever could get before he called the doctor. She had started to feel better on 28Dec2020. Then she was down again. She didn't feel great when she went to bed and then was up from 1AM to 2AM until now (28Dec2020). From 1AM or 2AM until 7AM or 8AM of 28Dec2020 it was the worse with bad aches and pains. She couldn't get comfortable. Alternating between fever and chills. Around 8AM to 9AM it started to get less and the aches started to get less. She didn't have a fever and he had checked 4 or 5 times. Around 2:00PM on 28Dec2020 she had the fever of a little over 100. The hot flashes were moderate to severe. The cold was worse and she was freezing in the middle of the night on 28Dec2020. He gave her heating pads and blankets and she was still freezing. Reporter thought the second shot would be worse with reactions. She was concerned about getting the second shot. No event required a visit to Emergency Room or Physician Office. No Investigation Assessment provided. The outcome of the events was unknown. This report was reported as non-serious.

development of rash on arms, itchy feeling on arms and torso; feeling of increased warmth all over body--temp 96.8 temporal but felt very, very warm took Benadryl rash faded, decreased itchiness

I went to the emergency room which after the Pfizer injection I had numbness sensation to my face and upper lips, nose and mouth. I feel a pulling sensation to her lips and nose. I have brain fog. I feel the injection affected a nerve in my face. She went to see her primary doctor put her on anti-histamine medication. She states she has no itching at the moment.

Cold/ cold like symptoms; Sore throat; Congested/ sore throat; Sore arm; I was hurting for a day; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) intramuscular on left arm at single dose for COVID-19 immunization on 23Dec2020 at 61-year-old. No medical history or concomitant medication. Yesterday (30Dec2020), the patient woke up with a sore throat, it was like getting cold with a sore throat, congested, the patient had cold like symptoms, seemed like the patient was getting a cold. The patient just took decongestant medication. After waking up this morning (31Dec2020) the patient did not have taken anything. The patient got tested for COVID (for antigen not a PCR) yesterday (30Dec2020) and was negative. The patient did not have got any fever, just sore arm a week ago (Dec2020). She was hurting for a day and then she was good, everything good. Action taken for BNT162B2 was not applicable. Outcome of the events was unknown.

Immediately after receiving the vaccine, patient developed sensation of throat numbness in the back of the throat. Patient denied SOB, wheezing, throat swelling, stridor, rash, chest pain, tongue swelling. One dose of diphenhydramine 25 mg PO suspension and referred to the Mount Sinai emergency department. Sensation resolved after a total of 30 minutes (10 minutes after receiving diphenhydramine). Vital signs and physical exam were WNL with the exception bilateral submandibular adenopathy. Patient was observed in the ED for approximately one hour with no clinical change and was subsequently discharged home.

Mild difficulty with thought/speech/concentration; strong wave of burning sensation growing inside the body; Lightheadedness; Blood pressure went up; Heart rate went up; Hands freezing; Mild difficulty with thought/speech/concentration; Mild difficulty with thought/speech/concentration; Weakness; Mildly shaky; Anxiety; Feeling that may pass out; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 61-year-old female patient received 1 dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686) via unspecified route on left arm single dose for COVID-19 immunization on 02Jan2021, 02:30 PM, at 61-year-old. Medical history: allergies to sulfa, paclitaxel (TAXOL); breast cancer in 2003 and 2007. Prior to vaccination, the patient did not be diagnosed with COVID-19. Concomitant medication in two weeks included: escitalopram oxalate (LEXAPRO, strength: 10m); omeprazole; multivitamin; ibuprofen. About 5 minutes after the vaccine (02Jan2021, 02:35 PM), the patient had a strong wave of burning sensation growing inside the body, lightheadedness, blood pressure went up, heart rate went up, hands freezing, mild difficulty with thought/speech/concentration, weakness, mildly shaky, anxiety, feeling that may pass out. Emergency room/department or urgent care visited. Treatment received for the adverse event included: heart rate H20 and BP monitor, water, observation. Since the vaccination, the patient did not have been tested for COVID-19. Action taken for BNT162B2 was not applicable. Outcome of the events was resolving. It was reported as non-serious per the reporter.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Mental impairment cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

left fingers felt cold and numb slightly light headed Felt 'goofy' and headache still feeling the same today - did register for V-safe

1st day of inj the expected side effect of inj site very sore and fatigue for 25 hours. Day 8 after receiving the vaccine, at 2 PM started with itching of scalp, arms, legs, rash, and abdominal hives. Proceeded to facial swelling and difficulty swallowing, swelling back of neck. Took 50 mg Benadryl w/ some relief. 630 PM symptoms reoccur, took another 50 mg Benadryl with no relief. Symptoms intensified to severe swelling of back of neck with intense pressure base of skull, radiating to top of head. Proceeded to the ER at 830 PM

Headache Malaise and frequent stools but not considered diarrhea Narrative: She states that she had immediate pain at the injection site. On Saturday at 7AM, she developed malaise and frequent stools but would not classify them as diarrhea as well as a headache. She has never had a fever. Today, she continues to feel weak but reports that she is improving.

Severe chills /tremors 14 hours following the second injection that lasted uncontrollably for one hour, headaches, fatigue, abdominal pain that cleared 1/7 in the afternoon. The nausea was so bad I could not eat. Vomited only one time. I missed one day of work, slept the whole day, and night, too.

pain in her whole arm; numbness in right cheek/numbness in arm/hand; Swollen lymph nodes; This is a spontaneous report from a contactable consumer. A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 30Dec2020 12:12 at SINGLE DOSE at right arm for covid-19 immunisation. Medical history included SVT this was recognized at least 20 years ago, around the age of 30, she started to deal with high blood pressure, allergic to penicillin. The patient's concomitant medications were not reported. The patient previously took codeine, levothyroxine: allergic to codeine, levothyroxine. The patient also previously took Tylenol with Codeine and that was horrible and she can't ever take it again, when she was around the age of 40 years old. The patient received the COVID vaccination around Wednesday 30Dec2020 at 12:12 p.m. She was perfectly fine until late Thursday afternoon 31Dec2020, around 3:30-4:00 pm. She started to have swollen lymph nodes. It was only a little bad at first and then she started getting more and more swelling. She spoke with her facility's RN who suggested she use some cold and warm packs/compresses and also take some Tylenol to deal with it. She has had the swelling for this many days now. It's not bad swelling but she her lymph nodes are still so swollen. She thought it was a regular reaction, but now it's been too long. Her lymph nodes are not swollen humongous. There is no redness. Her lymph nodes are not hard, just swollen. The swelling was a little bit better on Friday and Saturday but yesterday, it started bothering her again. She has had pain in her whole arm on an unspecified date. On 03Jan2020, her face also started to feel funny. She clarifies by "feeling funny", she meant she started to experience numbness in her right cheek, only her cheek, like when one gets a vaccination when they go to a doctor's office/dentist office and it starts working and one can feel it getting numb. She also experienced numbness in her arm. She clarifies when she puts pressure on her arm (like putting her arm on the desk), she feels numb in her hand. She verifies the numbness in both her cheek and arm started occurring on 03Jan2020 around 7-8pm. She is fine today and then she'll start to feel the numbness again in her cheek and arm. She clarifies the numbness comes and goes. It comes in the morning and then goes away and then the numbness starts again. She started to feel numb in her face and cheek, like when one gets a Novocain at the dentist office and it starts working- it's like the same feeling. The outcome of the events Swollen lymph nodes and numbness in right cheek/numbness in arm/hand was not recovered, while unknown for the other event. Information on the lot/Batch number has been requested.

About 5 minutes after receiving vaccine: suddenly- Felt hot all over; feeling of anxiety; and left deltoid muscle felt completely numb; palms slightly flushed, felt as if heart rate slightly elevated, but not tachycardia. No rash, no hives, no difficulty breathing. Acute episode lasted about 20-30 minutes, then just felt a little off for 1.5 hours more, then back to normal. For next 34-48 hours-mild fatigue.

First dose given 12/18/20 with expected muscle stiffness soreness later that evening and the next day. Dose two given on 01/07/21 with onset of shaking chills on 01/08/21 at 2:00am, ensuing fever max 101.7 degrees Fahrenheit, at 4:00 am noticed redness of eyes, face flushed with burning feeling, headache, dizziness, blood pressure of 184/96 and heart rate of 153. This required medical evaluation and treatment with IV fluids and Toradol for resulting headache. Patient also self administered 1000mg oral Tylenol prior to ER evaluation.

muscle pain in left shoulder blade and under left breast; rash which resembles shingles without blistering; redness on left should blade and over left breast

Numb hands, numb face, lightheaded, almost passed out, spike in blood pressure, unsteady walk. Ambulance called, tested to rule out stroke and blood sugar issue but tested ok. Determined I had allergic reaction to vaccine.

24 hrs- chills, Headache,LA sore, wheezing, fatigue Took Tylenol 3 times, using Proair inhaler 48 hours- more chills, more wheezing, LA still sore Took Tylenol twice, using inhaler 72 hours- LA still sore, skin red over deltoid and biceps with tenderness, still wheezing, using inhaler throughout day Symptoms somewhat controlled with repeated doses of Tylenol and Proair

I had diarrhea, numbness in my face, high blood pressure. 9 days of symptoms. The symptoms started a few days after.

Lymph node swelling under left arm and aching down left arm and side of chest. Lymph node painful to touch.

After patient had received vaccine, a vaccinator was called by a member of the healthcare facility to assess the patient. The patient was jittery and exhibited signs of confusion approximately 20 minutes (3PM) after her vaccination. The vaccinator asked if she was diabetic and the patient replied "yes" and takes metformin. Further questioning revealed that the patient had not eaten since 9AM - it was then around 3PM. The ambulance was called and the patient went to the hospital. Probe revealed that she had not taken her diabetic medication and that the patient had not eaten or drink. Patient was encouraged by vaccinator to eat on time and take her medicine as prescribed.

Arm pain post injection Severe pain in shoulder joint, down arm, pain elbow, pain firearm and hand on left side. Diagnosed as reactive arthritis due to vaccine

Red cheeks hot face dizzy shortly after. Had to pull over and needed my son to come get me. Two hours later cheeks still red not as red. Am home. Don?t feel normal. Very dry mouth and throat.

Extreme fatigue, hard chills, fever of 100 for several hours, nausea, generalized weakness. Chills and extreme fatigue lasted 4 hours. Low grade fever lasted 12 hours.

Initially mild nausea, moderate abdominal cramping for 30 minutes then severe watery diarrhea and moderate to severe abdominal cramping with moderate chills lasting 6 hours. Any fluids taken ran right through me. 4 lb weight loss and muscle cramping from dehydration. 12 hours after symptoms started I was able to take fluids and eat crackers. 24 hours after start felt shaky with mild abdominal soreness but improvement progressed and by 28 hours after start if symptoms felt normal other than I felt like I did 100 sit ups!

On my drive back to work after getting the vaccine the left lower part of my face when numb and tingly. Then it focused on my left nostril. The overall effect didn't last long but my nostril still doesn't feel right. Somewhat numb but not always. The left side of my face feels strange at times as well. Hard to explain.

Was premedicated with Medrol, Singulair and Zyrtec 20 minutes after vaccine developed paresthesias of both sides of lower face, lips and face swelling. This resolved in @ 20 minutes. Next day developed excessive fatigue with difficulty talking and a heavy sensation in the chaste with an event of fullness sensation of the right soft palate and tongue.. This became worse on the second day for which needed treatment with Medrol pack and antihistamins.

Woke with chills & shaking. Temp was only 99.3 oral at that time. Took Motrin 800mg. Significant body aches & pain. The next day, 1-13-21, Temp 100.4, continued body aches, very tired & sleepy. Sore right arm, body aches from head to toe. Taking Motrin again.

About 30 minutes after taking the vaccine, when I was driving home, my face got very hot and red. I also started feeling lightheaded like I might faint. I pull over into a parking lot and had a family member come get me to drive me home. I was extremely thirsty and drank a lot of water at home. Eventually, my redness went away and my face did not feel as hot. I did feel other more typical symptoms too such as painful arm, and flu like symptoms. I am mainly concerned about the reaction I had when driving home since it was similar to what happens when I take cortisone or Doxycycline. I am needing information as to whether it is safe for me to take my second dose of the covid vaccine.

At time of shot, maybe 3 mins after, rush of hotness through entire body and severe nausea. Passed after about 4 mins then occurred a second time lasting for about 5 mins. Rested for about 45 mins before I felt well enough to drive. All better after about 2 hours.Next day, tired, sweaty, nauseous, lightheaded when standing.

Pt received vaccine at 0730 on 1/11/2021. She developed fever, chill, body aches and headache at midnight the same day. The following day shew had a fever a high as 103. She continued to feel fatigued, achy, headache, slightly nauseated and weak. Her symptoms improved over the course of the last 2 days. She is fever free today

Systemic: Anaphylaxis-Severe, Systemic: Fainting, Systemic: Pharmacist submitting: unable to determine if anaphalaxis or panic attack, patient experienced facial weakness, chest tightening, tremmors, inability to breathe, and fainting within 10 min of administ

Chills; Diarrhea; Again today 24 hours later she had abdominal cramping that was almost debilitating; Abdominal cramps; This is a spontaneous report from a contactable consumer. A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on the right arm on 07Jan2021 07:00 at single dose for COVID-19 immunisation. The patient had no medical history. There were no concomitant medications. The patient experienced abdominal cramps on 07Jan2021 13:30, diarrhea and chills for 20 or 30 minutes and then it all went away on 08Jan2021. Again today 24 hours later, she had abdominal cramping that was almost debilitating. Had Covid 19 Test up the nose test, thinks it was PCR that was negative on 06Nov2020. The outcome of events was recovered on 08Jan2021.

DEVELOPED SORE ARM THAT LASTED 1 DAY. ALSO HAD BAD FATIGUE AND HEAD PAIN LASTING UNTIL MORNING OF 1/10/21.

Patient instructed to wait 30 min post vaccine administration. After 30 min patient reported feeling flush and cheeks were slightly red. O2 sats 98%, HR 62 bpm, denies shortness of breath. Notified Dr. who gave a telephone order for Benadryl 25mg PO now. Instructed patient to stay 30 additional for observation post Benadryl administration.

Pfizer-BioNTech COVID-19 Vaccine EUA. //Symptoms began 12 hours after with increase soreness at injection site radiating up and down arm and up into neck ; Body aches especially lower back developed within 24 hours with a severe throbbing type headache and ringing in the ears. Elevation of temperature by 1-2 degrees normal for me runs 97 degrees F and was up to 99 degrees F. Headache intensified with movement(ex. .bending over ,etc) Treated arm soreness and lower back with heat compresses... elevated temp and headache with rest and a lot of water. It is now over 48 hours since vaccination and all symptoms are subsiding but still present with temperature normal for me and no arm soreness. Scheduled day off from work day after vaccination but also a second day due to the severe headache mostly.

Received the 2nd vaccine at 10am on 1/11/21 intramuscular in the right arm. At 3pm on the same day, I had a painful swolle lymph node on left side of neck. That same evening I developed pain, swelling, in my right armpit radiating to the right upper breast and down my right arm with a swollen lymph node under the right arm pit. The pain was about a number 7 on a scale of 1 to 10. The pain and swelling still persist today on 1/15/2021 Still painful, especially to touch. Still radiating down the arm. Lymph node still swollen The pain is about a 2 on a scale of 1 to 10

Shingles type reaction without a rash or redness; Extreme skin sensitivity on torso (chest and back) on left side of body parallel to injection site.; This is a spontaneous report from a contactable pharmacist (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EJ1685), via an unspecified route of administration on the left arm on 22Dec2020 07:45 at SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included diabetes and hypertension (HTN). It was also reported that the patient had allergies with quinolones. Concomitant medications included metformin (METFORMIN), cetirizine hydrochloride (ZYRTEC), semaglutide (OZEMPIC), simvastatin (ZOCOR), levothyroxine sodium (SYNTHROID) and "elav". On 01Jan2021 19:00, the patient had extreme skin sensitivity on torso (chest and back) on left side of body parallel to injection site. The patient also had shingles type reaction without a rash or redness. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. The patient did not receive any treatment for the events. Outcome of the events were not recovered.

but then yesterday (10Jan2021) her stomach was hurting and she had a headache but no fever; but then yesterday (10Jan2021) her stomach was hurting and she had a headache but no fever; Got the vaccine early Friday afternoon and had a sore arm; This is a spontaneous report from a contactable consumer (patient) reported that a 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient got the vaccine early Friday (08Jan2021) afternoon and had a sore arm but then yesterday (10Jan2021) her stomach was hurting and she had a headache but no fever. The patient asked if that normal for side effects to occur 2 days later. The outcome of the events was unknown. Information on the lot/batch number has been requested.

immediate metallic taste in mouth accompanied by tachycardia to 120 (usu pulse is 65) followed by unusual feeling in mouth, not itchy, but tingly-type sensation. lasted about 1 1/2 hours, same reaction happened with both first and second doses, the second time was a little more intense and longer lasting.

2nd and 3rd branches of trigeminal nerve, bilateral, more left than right: odd feeling throughout muscles, tongue felt thick, mild tongue coordination alteration. Left 2nd and 3rd branch trigeminal nerve mild numb sensation though unclear if I have mild paresis too. Mildly reduced tongue coordination continues.

Hands are hurting, looks like I have some bleeding under the skin on my left hand, middle finger, hands are swollen and have a spotted look on the underside. Tried taking over counter meds, nothing is helping with pain.

Was cold, took a shower, got out , couldn't get warm. Freezing and shaking, nausea, tingling in left side of face, joint pain, headache and neck pain. Lasted about 3 hours, shaking stopped but had chills that lasted all night. The next day, no appetite but when she ate something, she vomited. Worse things were shakes, headache and neck pain and vision. . Had vision problems. Eyes were swollen and jittery and hard to focus. The swelling went away but still unable to focus. Everything has gone except vision issue.

DIARRHEA 01/09, 01/10, 01/11, HEADACHE 01/09THRU 01/19 VERY TIRED 01/09 THRU 01/19 NAUSEA 01/09 THRU 01/19 SORE ARM 01/09 THRU 01/19

Severe Left Leg Pain, thing started about three hours after the shot and it so severe screaming and needed pain medicine . The next morning left work due to pain . 12/28/2020. Physical Exam and called it sciatica but not what it was It was inflammation of left fascia lata the Tramadol 50mg and Percocet 5 mg and Prednisone 5 days and it was better by 90% after receiving second shot worsened for a day then back 90%

Though I had pain and soreness in the arm after both the shots I am left with a residual weakness and ache in the arm almost a month later. I find I am not able to lift items that I was able to lift last month and there is a lump in my left upper arm that is new as well.

she had blister on the right side of the tongue /has blisters on her tongue or maybe ulcers; she had blister on the right side of the tongue /has blisters on her tongue or maybe ulcers; rash on the neck; which was burning /burning on skin where the rash is; had difficulty in breathing due to congestion in throat; had difficulty in breathing due to congestion in throat; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685 and expiration date not provided), via an unspecified route of administration (right arm) first dose on 07Jan2021 15:45 at single dose for covid-19 immunisation. The patient's medical history ongoing Asthma, ongoing Psoriasis, ongoing Eczema, and ongoing Osteoporosis. There were no concomitant medications. The patient stated yesterday she got the vaccine, about a half hour later her neck started to get red like a rash, and as the evening went on it felt like burning on her skin at the rash. She had a hard time breathing last night and had to sit up to sleep. Then this morning she had a blister on her tongue.The patient clarified the first dose of vaccine was on 07Jan2021 at 15:45 PM in the right arm. She noticed about 30 minutes later, a rash on the neck and then burning on the skin where the rash was that evening; then that night she had a hard time breathing and had to sit up to sleep due to congestion in her throat. She had to keep clearing her throat. This morning (08Jan2021) she noticed she has blisters on her tongue or maybe ulcers, just on the right side. Asking should she take some Benadryl? Was this expected side effects?. The patient wanted to know find out if she should get the next dose? The patient relevant tests include COVID 19 test on 07Dec2020 and it was negative. The outcome of the event Neck rash was recovering and not recovered for the remaining events.

After waiting 15 mins I developed a dry throat and walked to my car (8-10 mins later). Began to develop difficulty swallowing by the time I reached my car. Waited a few minutes and it did not abate and continued worsen,. Went to hospital's ER and was seen by Dr. At that time, my voice had become coarse and gravely. Was given oral steroid and a Benadryl. Symptoms lessened a bit and were gone after about 2 hours. While at first I thought my breathing wasn't affected, after symptoms cleared, I realized that my breathing was easier. Symptoms did not reoccur.

Dose 2 given at 1208 on 1/20/2021. At 1232 pt noticed flushing in the arms b/l, persistent pins and needles in arms, hands, and feet b/l, with "slight tingle" in lips. Unusual taste in mouth (that happened after 1st dose as well). Small wave of nausea. Sensation of heat in chest. At 1301 on 1/20/2021, 50 mg of IM Benadryl administered to RD (Lot # 080010, Exp 8/20/2022) by NP. At 1320, arms were less flushed, however b/l pins and needles persistent in both arms and feet, with "tingling" still in lips. Pt will wait until symptoms improve further to d/c to home. NP checking in continuously.

Due to hx of allergic reactions, pt was told to wait for 30 minutes in observation prior to vaccination. At 1208 on 1/20/2021 pt received 2nd dose of COVID Pfizer vaccine. Immediately after vaccination, pt experienced unusual taste in mouth, flushing, and feeling of heat in chest. At 1232, pt noticed flushing on arms and feelings of heat and pins and needles in both arms, hands, chest, both feet, and back. Sensation was persistent, so at 1301, 50 mg of IM Benadryl administered to RD by NP. By 1320 flushing on arms and chest subsided, feeling of pins and needles persisted but was not as severe as initial reaction. By 1345 flushing on arms returned, pins and needles sensation worsened again in all locations noted prior, spread to scalp, and tingling sensation occurred on lips. Pt communicated with Dr advised to stay under observation, but transfer to ED not medically necessary. At 1415, pt was advised to go home with supervision of partner and monitor symptoms from there.

I had an immediate reaction to the covid vaccine within 30 seconds after the injection. I felt a warm sensation after the vaccine in my deltoid muscle then felt it go up both my ears, around my head. I then felt the same warm sensation in my abdomen, followed by buzzing of my entire body with light headedness. I could breath, I could talk, but I had an urgency for others around me to know that I wasn?t feeling well and something was not right. I asked my colleagues if someone could take me to the ER for monitoring. They immediately put me in a recliner and elevated my legs. This did not relieve my symptoms and asked to go to the ER. I got to the ER and laid on the stretcher with continued increased buzzing sensation especially in my finger tips and arms. My vital signs were 148/88 and HR 88 (elevated from my normal of 100-120/60-70, HR 60s). The buzzing turned into a sensation in my arms that rumbled erratically. I thought something bad was about to happen and that my blood cells would burst. Then I also felt icy cold in my arms and my gut. Next what happened were teeth chattering shivers. All these symptoms occurred in a matter of minutes. They started an IV, drew blood, gave me Benadryl and ran IV fluids. My vitals did not reflect what I felt inside, but as symptoms let up, my VS returned to normal. As quickly as the symptoms started, they eventually calmed down and I was able to leave the ER in 1.5 hours to go home. I was very scared. The ER doctor thought I had a hyperimmune response to the vaccine.

Second, dose 1/16/21 Pfizer LOT: EL3248 Saturday 11:30 am ? Side Effects started about 1.5 - 2 hours after injection (I took 2 Tylenol and took a 3 hour nap) o Tired o Left Eye twitch o Blurred double vision o Headache o Nauseous ? Side Effects started about 5 - 6 hours after injection (I took 2 Tylenol a Benadryl and used my Ventolin inhalator) o Tired o Watering eyes o Sore tongue o Headache o Nauseous o Heavy feeling in chest ? Side Effects started some time during the night after injection o Muscle cramping in both legs and opposite arm of injection site o Low fever 100.3 Sunday side Effects (I took 2 Tylenol and took a 3-4 hour nap) o Tired o Left Eye twitch o Watering eyes o Sore tongue o Excessive thirst o Swollen neck glands o Nauseous (only after eating) o Muscle cramping in both calves o Blurry vision in the evening o Runny nose Monday side Effects (Went to work) o Tired o Left eye lid twitch o Swollen neck glands o Nauseous o Runny nose o Achy body o Diarrhea Tuesday side Effects (Went to work) o Left eyelid twitch o Swollen neck glands o Runny nose o Sore throat o Diarrhea BLOODY Wednesday side Effects (went to work) o Swollen neck glands o Runny nose o Sore throat Note: I have several Allergies that require me to take an allergy pill every day. I also use an inhaler as needed. My symptoms were not any worse than when I have a bad allergic reaction, I have received shots of Epinephrine for my allergies and did not feel one was necessary.

Approximately 9 hours after vaccination, pain in injection arm became much worse, a pain rating of 6 to touch and on abduction. About 11 hours after vaccination, I became increasingly uncomfortable, feeling warm, chills, muscle aches. I could not sleep. 22 hours after vaccination, my temperature was 101 F (did not take it before this time). Temperature waxed on waned from that point (day #2). About 36 hours after the vaccine, my temperature stabilized to normal. 48 hours after the vaccine, I felt better and better with each hour.

felt very uncomfortable; Mental fogginess; Nausea; Dizziness/Lightheaded; Vertigo; Some extreme fatigue; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL0140 and Expiration Date: 31Mar2021), via an unspecified route of administration in the right deltoid on 27Dec2020 at a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included progesterone (MANUFACTURER UNKNOWN), estradiol (MANUFACTURER UNKNOWN), testosterone (MANUFACTURER UNKNOWN); all taken for hormonal treatment from an unspecified date to an unspecified date. The patient experienced the following events and outcomes: some extreme fatigue (non-serious) on 27Dec2020 with outcome of unknown, nausea (non-serious) on 31Dec2020 with outcome of unknown, dizziness/lightheaded (non-serious) on 31Dec2020 with outcome of unknown, vertigo (non-serious) on 31Dec2020 with outcome of unknown, felt very uncomfortable (non-serious) on an unspecified date with outcome of unknown, mental fogginess (non-serious) on an unspecified date with outcome of not recovered. The patient stated she wanted to report her experience with the first dose of the Pfizer Vaccine (COVID Vaccine), which was received on 27Dec2020. The patient stated she experienced some extreme fatigue starting that first day and then about four days later on 31Dec (not clarified), she experienced some nausea, some dizziness that advanced to vertigo and that occurred late at night; at the time she was getting ready for bed time around 22:00, but it just lasted for about one hour. The patient "went to bed just thinking about and staying in bed and then I felt very uncomfortable and I got up and then I went back to bed about at 01:30, that's how I just fell asleep." Then the next day, the patient was not feeling the vertigo, however, she was feeling lightheaded for about two days and then the fatigue continued to 08Jan (not clarified). Then starting on a Saturday, the patient "felt normal myself energetic and positive." The patient was still feeling mental fogginess, " I was getting here." The patient stated that dizziness and vertigo, or the mental fogginess were not listed on her list of possible side effects. The patient even asked her doctor what it would be, and the patient let her know that she received the vaccines. The events did not require any emergency room or physician office visits. The causality assessment from the reporting patient was reported as: "Yes, I believe it did."

sensitivity to cold; feeling chilled; short of breath (SOB) with minimal exertion; This is spontaneous report from a non-contactable nurse reported for herself. A 61-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) intramuscular in the left arm on 08Jan2021 12:00 at single dose for Covid-19 immunization in a hospital. Medical history included COPD, hypothyroidism and allergies to penicillin (PCN). The patient was not pregnant. The patient has no COVID prior vaccination. Concomitant medications included fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY), montelukast sodium (SINGULAIR), oxybutynin, and azelastine; all from unspecified date for unspecified indication. The patient previously took Celebrex and experienced allergies. Historical vaccine included first dose of BNT162B2 intramuscular in the left arm on 20Dec2020 09:15 (61 years old) at single dose for Covid-19 immunization in a hospital. The patient has no other vaccine in four weeks. On 08Jan2021 15:45, the patient experienced sensitivity to cold, or feeling chilled for 48 hours post dose, short of breath (SOB) with minimal exertion for 72 hours post dose. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was not COVID tested post vaccination. The patient did not received treatment due to the events. The outcome of the events sensitivity to cold, or feeling chilled, short of breath (SOB) with minimal exertion was not recovered. No follow-up attempts are possible, information about batch number cannot be obtained.

I was at work yesterday morning and began to feel shaky. Progressed to both hands trembling; legs feeling weak and wobbly. Could not perform my work duties. Progressed to Rigors. Lasted at least 3 hrs in it's severest form. Now, 24 hrs later I still have some hand tremors, and legs are weak. Shoulder, knees, hips achy. I'm very fatigued. Right arm soreness @ injection site. All events were reported. I was sent home from work, had to be driven home. I rested, slept and hydrated the remainder of the day. Did not go to work today.

STarted having nausea around 10am on 1/21/21, then at noon started having chest pain and a migraine. Went home early from work. As of 1/22/21 0830, still has chest pain but not as intense and it radiates to left shoulder and towards back (advised employee to have this evaluated)

Rash in my chest, under my breast and some in the side. Experience some tingling, itching in my legs.

Left fingers tingling 10 minutes post vaccine. Next day felt it spread to whole left side and left eye felt "weird." Took Advil, got better after no difference with Tylenol. Then stopped the Advil and symptoms persisted. Then had tingling of head and neck. Saw her physician and Carotid flow study was normal. Waiting for MRI approval. Has been working with the symptoms.

Malaise, High Blood pressure, fainting, tachycardia, thready pulse, facial drooping, chest discomfort, disoriented, feeling a sense of impending doom.

Patient seated in observation area for a 30 minute observation after injection of Covid 19 vaccine. Patient after 5-10 minutes stated she had tingling to tongue and lips. Shaking noted to hands and patient stated she felt numbness to upper extremities with dizziness then felt light headed. Patient transported to first aid room for further assessment and observation. Patient was A&O x4, lungs clear to auscultation, patient stated she felt like she needed to take a "deep breath". Patient had O2Sat of 95% on RA and B/p of 130/80. at 1016 covering provider ordered to give patient given 12.5mg of Benadryl liquid with 16oz of Water intake during observation period. Continued to monitor patient and noted that was able to ambulate at 1025 to bathroom with assistance but still experiencing dizziness. Patient monitored for a total of 45 minutes then discharged home.

Pfizer-BioNTech COVID-19 Vaccine EUA I went to bed at 8 pm and noticed my arm was sore. I awoke at 11 pm to use the restroom and when I returned to bed I had a cough and SOB. This continued with copious secretions with worsening over time until I was fighting for air at 4:30 am. My husband called the ambulance because he did not feel he could get me to the hospital in time. In the ambulance I was started on 4L of O2. Upon arrival at the ER I was given a breathing treatment and started on the BiPap. I was admitted to the hospital and received 3 more breathing treatments and recovered to be on room air by 11:00 pm. The tests and observations, the doctor reported that there was no other cause than the vaccine.

After first dose I felt an overall odd feeling . no shortness of breath etc, just odd. I was thinking it may have been just some anxiety. I left the center after 15 minutes and came back to Pediatric office where I work. I did take a Zyrtec and felt completely better after approx. an hour. After the 2nd dose I did mention I had felt odd after 1st dose and decided to sit for 30 min. I felt about the same as I did after the 1st dose so I left. when I got to my car my face was flushed. I was not tachycardia just a very odd felling in my head and then my tongue did start to itch (or feel funny) . I took a Zyrtec and went home. I never had any swelling of lips or tongue, no trouble breathing. Pulse stayed constant around 80. This time the symptoms lasted approx. 4 hours. I I did continue to take Zyrtec for 3 days after injection.

Approx 18 hours after the vaccine: Cold and hot flashes with chills (no fever) weakness, fatigue, slight left arm ache, loss of appetite, insomnia, body/joint aches. I took a couple of Aleve tabs 24 hours after the vaccine and then switched to 500 mg Tylenol 30 hours after the vaccine, with no relief of symptoms from either meds. I've been sleeping (taking 2 hour naps) and called off of work (I work in home health). Today, 1.27.21 I feel better, still having 'hot flashes' and some chills (again, without fever). I feel tired, slept last night for 12 hours (no further insomnia). I am eating, but really have no appetite.

Monday afternoon, January 25, I started feeling achy and chilly. Just not well. I work 5 a.m. to 1:30 p.m. I went straight home from work. I took shoes off and got in bed. I was very cold and felt that the coldness was from inside out especially in my hands. I covered with a sheet and 3 blankets with an extra blanket to my feet and used winter gloves on my hands. I got up at 5 p.m and felt better. Tuesday morning, January 26 at 3 a.m. when I got up to shower, I noticed a soreness and large swelling under left armpit, ? lymphadenopathy. All others symptoms had passed. Continues to be the same on today, January 27. Seeing MD on Thursday, January 28.

felt cold and chilly; can't move her arm up and down; Fever/ 101.2; body aches; mild pain in arm; This is a spontaneous report from a contactable consumer report self. This 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL4176), via an unspecified route of administration at left arm on 12Jan2021 14:30 at single dose for covid-19 immunization. Medical history included COVID in Nov2020 (Patient was tested for Covid on 23Nov2020 and found out the 25Nov2020 the result was positive), she just quarantined herself at a hotel (They gave her Benzonatate, but she was also taking Tylenol 500mg and Robitussin DM). Concomitant medications not reported. Patient did not get any other shots or 4 weeks prior. No problems with vaccines in past that she can remember. No additional vaccines administered on same date of the Pfizer suspect. Patient received the Pfizer BioNtech vaccine on 12Jan2021 and after that on 12Jan2021 night she didn't feel anything but mild pain in arm, it was so painful, but not as bad on 13Jan2021 even though she still has it. She can't move her arm up and down. On 13Jan2021 morning at dawn she had a fever and it is now 101.2. Has taken Tylenol 500mg (Lot number: SLA071, UPC number: 30047112, Expiry Date: Aug2024). Patient had body aches started 12Jan2021 at midnight (12:00) that is start date of 13Jan2021. She felt cold and chilly and not sure if it was the weather or her. No Emergency Room or Physician Office visit. The outcome of "felt cold and chilly" was unknown, of else events was not recovered.

unable to work; ESR of 124 mm/hr; CRP of 4 mg/dl; difficulty with ADLs; neck and leg muscle stiffness and pain; neck and leg muscle stiffness and pain; difficulty ambulating; neck and leg muscle stiffness and pain; fatigue; body aches; chills; sweats; This is a spontaneous report from a contactable physician (patient). A 61-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via an unspecified route of administration at left arm on 18Dec2020 at single dose for COVID-19 immunization. No medical history. The patient's concomitant medications were not reported. Patient had been otherwise well prior to receiving the bnt162b2 on 18Dec2020. Within 72 hours, she experienced fatigue, body aches, chills and sweats since 21Dec2020, though she was able to work Xmas week. On 31Dec2020, she contacted her PCP to report neck and leg muscle stiffness and pain, difficulty ambulating, fatigue, chills and sweats. She had a negative COVID test on 02Jan2021 and essentially negative blood work, other than an ESR of 124 mm/hr and CRP of 4 mg/dl. I had a negative PET scan on 12Jan2021. Currently, she had pain/stiffness in her neck and legs, and progressive difficulty w/ ambulation (both of which are worst in the early hours of the AM), and difficulty with ADLs since 31Dec2020. She had been unable to work since 03Jan2021. Her physician had not indicated or endorsed any relationship between her symptoms and the vax. She forewent dose 2 out of an abundance of caution. The adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment received. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: The events muscle stiffness , neck pain and gait disturbance appeared 13 days after administration of single dose BNT162B2. The Company considers that the events are less likely related to suspect BNT162B2 injection given the weak time association. The detailed clinical course and cause of the events would be helpful for further assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

10 -15 minutes after shot: Swelling of tongue; drainage from nose and back of throat;gourde voice; trouble swallowing : elevated blood pressure Told nurse 25 minutes later.given benedryl injection Things improved and an hour later tongue began to swell again and blood press increased Paramedics called and they transported me to the ER where I was given an Epi injection and steroids. Monitored for three hours and sent home with prescription for steroids: epi pen; and zyrtec Still experiencing fatigue , headache and lots of drainage off and on

A little over 48 hours into my COVID19 shot (Pfizer), I got sick. I was freezing cold, slight headache, no appetite, and tired/achy. I slept for 3 hours and woke up a little after 8 p.m. Temperature was 100.5. After calling work and notifying my doctor, I drank a Powerade and went to bed. This morning, I feel almost normal. Slight headache (maybe from lack of food) and my stomach is still a little upset.

Client was being treated with antibiotics by her PCP for diverticulitis flare up. It had not been resolved on the date of her death which occurred 01/27/21, She was found unresponsive by staff, 911 contacted, and paramedics pronounced her deceased at 7:48 AM. After consultation with PCP manner of death was noted as cardiac arrest. PCP was to sign off on death certificate.

Fever 101; pain in both thigh; chills; nausea; headache; This is a spontaneous report from a contactable nurse (patient herself). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140, expiry date not reported), via an unspecified route of administration in the left arm on 13Jan2021 13:00 at single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome (PCOS). Concomitant medications were none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. On 14Jan2021 01:00, the patient experienced fever 101, pain in both thighs, chills, nausea and headache. No treatment was received for the adverse events. Clinical outcome of the events was recovered with sequelae on Jan2021.

Increased HR, Weakness, Throat Irritation, Diaphoresis. Patient was asked to sit in observation for 30 min. Hx of allergies. Very anxious, anxiety causing increased HR and Sweating. throat itching/tightness. Legs elevated, 50 mg of Benadryl given.

about 30-45 minutes later started feeling numbness on left side of face; left lower lip remained slightly numb; This is a spontaneous report from a contactable nurse. A 61-year-old female nurse reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EJ1686), intramuscular at single dose into the left arm on 08Jan2021 at 03:30 PM for COVID-19 immunization. First dose of BNT162B2 was received on 18Dec2020. Medical history included rheumatoid arthritis, coronary artery disease and hypertension. Past drug history included NSAIDS which caused bleeding. The patient's concomitant medications were not reported. The patient reported that about 30-45 minutes after vaccination she started feeling numbness on left side of face and left lower lip remained slightly numb. The events were reported as non-serious. The patient did not receive any treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.

headaches; achy feeling; nausea; felt hot; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL3249) via an unspecified route of administration in the left arm on 12Jan2021 09:15 AM at a single dose for COVID vaccine. Medical history included rheumatoid arthritis. Concomitant medications included leflunomide, paroxetine, and ergocalciferol (VITAMIN D) (other medications in two weeks). The patient had no other vaccine in four weeks. The patient had known allergies to sulfamethoxazole/trimethoprim (SEPTRA) and mefloquine. It was reported that the patient had 4 days of headaches and achy feeling on 12Jan2021. During her 30-minute wait after the injection, she experienced some nausea and felt hot on 12Jan2021. Treatment was not received for the events. The patient had no COVID prior vaccination. She did not have COVID tested post vaccination. The outcome of the events was recovering.

tired; sweaty; nauseous light headed when standing; rush of hotness through entire body; severe nausea/nauseous light headed when standing; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (Lot number: 3302), via an unspecified route of administration in right arm on 13Jan2021 13:00 at single dose for covid-19 immunization. Medical history was none. Concomitant medication included escitalopram, vitamin d. At the time of shot, maybe 3 mins after, rush of hotness through entire body and severe nausea. Passed after about 4 mins then occurred a second time lasting for about 5 mins. Rested about 45 mins before feeling well enough to drive. All better after about 2 hours. Next day (14Jan2021), tired, sweaty, nauseous light headed when standing. No treatment received. No pregnant at the time of vaccination. The outcome of the events was unknown.

Fever, chills, weakness, body ache, dizziness didn't get out of bed for over 24 hours. Took Tylenol for relief. still feeling weak. can't stand up long without feeling dizzy.

day after shot. Woke up at 3:00 Am with severe pain in my right arm with redness and swelling around the shot area.

Bells Palsy Signs and Symptoms Right Side for the last 72 hours with ear pain and eye twitches. noticeable onset this morning 1/30 with right eye right and upper lip involvement.

alost fainted- very pale, then tachycardia, high blood pressure, diarrhea. This reoccurred i waves over the next week. Also fatique,, muscle and joint pain. for 6 days also had sever headace, numbness in face and lips, spasm of left eyebrow. Mised wek of work, ended up in Emergency room. Had negative covid test. sent home. Was fatiques and dizzy and brain fog for next three weeks. Took a month to feel rigtht.

in first half hour, heat/flush came up the left side of neck and face up to eye. inside of ears felt warm. extreme tinnitus. took Benadryl and slept. after 5 hours, symptoms came back. feels like lower jaw is pulling to right. took more benadryl.

12 hr after vaccine, sore arm, a little achy. 15 hrs after vaccine (11 pm) and through the night, felt very cold and had difficulty getting warm, headache, all body achy, unable to get into any comfortable position and very limited sleep. By 24 hr after vaccine and continuing until 40 hr after, nausea most of day, severe muscle pains, headache, difficulty moving from pain and general weakness, head swimming sensation. felt like skin crawling sensation all over. By 48 hrs, much less headache and nausea, able to eat, still had skin crawling sensation and achy but able to walk around a bit, not able to go outside. By 58 hr after (at time of report), just weak all over feeling, head fuzzy but better. Treatment: ondansetron x 2 doses (at 24 hr and 20 hr), Nurtec x 2 doses at 15 hr and 20 hr), Acetaminophen 8 hr x 2 doses (at 36 hr and 48 hrs)

Metallic taste in her mouth. Violent shaking for 11.5 hours and pulled muscles in her stomach and back. Injection site hot. Fingers on that side were white Dizziness. H/A. Vomiting

Received second dose of Pfizer COVID vaccine on 1/17/2021 at about 10:30 am. Started having soreness in arm, headache, and fever of 99.4 at about 2:30am on 1/18/2021. Side effects persisted all day on 1/18/2021 but relieved with acetaminophen 325mg every 6 hours. All side effects resolved by morning of 1/19/2021. Around 4:30pm on 1/19/21 started having pain in left axilla which was due to swollen lymph node. The pain and swelling progressed over the evening and pain radiated to chest, throughout left arm, and shoulder. All of these side effects continued all day on 1/20/21 but started getting better around 6pm. All side effects resolved by morning of 1/21/2021.

Severe sudden diarrhea, headache, weakness, taste of smoke with burning sensation. Today unable to do anything, very tired.

I'm not sure if this is related; Was at work in out patient hospital facility and placed a mask on from a new box. I noticed my nose was itching a bit (I'm very sensitive to certain masks and usually air them out) A little while later I had an intense itching / prickly, sensation in my nose and started itching on my face under the mask. I took it off and found a different brand and took some benedryl. Seemed to get some relief and later that evening, I started to itch again including my head and inside ears, face had flushed with hive like rash. This continued throughout the weekend on and off eventually my whole body was randomly itching/tingly. No problems breathing. Took allergy meds and felt good but noticeably annoying. Called our covid info line on Monday and they gave me a few numbers for allergists. Mine retired. Had an appointment Tuesday morning. Dr felt it probably was reaction to mask not vaccine. Did a patch test with a piece of mask and did itch some but had a reaction to the tape that held the piece of mask in place so results not good. Took medrol dose pack and increased allergy meds. Still itching on and off randomly all over body, not as severe Delaying second vaccine by a week or two until this resolves per DR

Slight fever/ her temperature usually runs 97 and currently is 99.4; joint pain because her hips hurt/ her hips were really sore; Chills; Arm pain; Headache/ pain at the base of the head/ pain in her head; Neck pain; Shoulder pain; pain everywhere; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ16R6), intramuscular in the left arm on 17Jan2021 09:30 at single dose for COVID-19 prophylaxis. The patient medical history was not reported. There were no concomitant medications. The historical vaccine included the first dose of BNT162B2 on 26Dec2020 at her 60-year-old for COVID-19 prophylaxis. The patient was a physical therapist (non- Healthcare Professional), she received the second dose and was having almost every side effects. She experienced arm pain started night around 17Jan2021 17:00; headache, pain at the base of the head, neck pain, shoulder pain, pain everywhere on 17Jan2021; chills that she couldn't get rid of on 17Jan2021 19:00; slight fever, and overall feeling tough, joint pain because her hips hurt on 18Jan2021. At 17:00-19:00 on 17Jan2021 and stated that she could not tolerate her head being upright. She stated that she went to bed at 19:00. Pain in her head, neck, and shoulders is a little better because she can actually sit up now and hold her head up. She said that her temperature usually ran 97 and currently was 99.4. She said that she did not take her temperature on 17Jan2021 and did not get up until 13:00 and stated that she took it when she got up on18Jan2021. She noticed joint pain when she got up on 18Jan2021, her hips were really sore. Chills started at night, when she went to bed she had the chills around 19:00 17Jan2021. The outcome of pain in her head, neck, and shoulders was recovering, of the other events was not recovered.

sluggish and wanting to sleep all day; Sneezing; stuffy head; Low grade fever; Chills; bad headache; arm hurts; The initial case was missing the following minimum criteria- No Adverse Effect. Upon receipt of follow-up information on 19Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: not provided - "has not received information card "), via an unspecified route of administration on 17Jan2021 at single dose on the left arm for COVID-19 immunization (reported as "Why was the patient taking Covid-19 vaccine (Verbatim): works in a group home "). Medical history included ongoing heart murmur since 2019. There were no concomitant medications. There were no investigation assessment. The patient experienced low-grade fever, chills and a bad headache on 17Jan2021. Patient was sluggish and wanting to sleep all day on 18Jan2021. Patient took Tylenol for a headache. It did not work so she took sumatriptan. The patient was also sneezing on 18Jan2021. Patient reported that she sweated the fever out. She had chills at night. The headache was lingering off and on but was mild. She sneezed all day on Monday (18Jan2021). She has not sneezed yet today but she has a stuffy head on 18Jan2021. Patient clarified that she took Acetaminophen Rapid Pain Relief instead of Tylenol. She took two 500mg tablets (UPC: 3225152303, Lot: 91670159AA, Expiry: Aug2022). Patient also reported that her arm hurts on 17Jan2021. She was unable to provide the Lot number. She will receive the information card after she receives the second dose. She had a picture of the card but it was not very clear. Outcome of the events arm hurts, headache, stuffy head was recovering (also reported as ongoing), for chills, low grade fever was recovered on 18Jan2021, for sluggish and wanting to sleep all day was recovered on 19Jan2021 while for other event was unknown. Information about batch/lot number has been requested.

thrush; weak; tested positive for Covid; tested positive for Covid; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685, expiry date: unknown), via an unspecified route of administration on 21Dec2020 at a single dose for covid-19 immunisation. Medical history included ongoing COPD (chronic obstructive pulmonary disease) (not really diagnosed with COPD), ongoing smoker (smokes about 10 cigarettes a day; has smoked 40+ years), cough. The patient's concomitant medications were not reported. It was reported that on 31Dec2020, the patient tested positive for COVID from which she went to the doctor and was treated on 14Jan2021. The patient was given SOLU-MEDROL injection just to help her because she has mild COPD to bring up all of the junk. She is clear now. She doesn't have pneumonia. Her labs were good. She feels 80% back. The patient also experienced weak and thrush on unspecified date. Therapeutic measures were taken as a result of the event tested positive for COVID which included antibiotic and a cortisone injection, and for the event thrush which included NYSTATIN mouth rinse. Outcome of the event tested positive for COVID was recovering. Outcome of the remaining events was unknown.; Sender's Comments: Based on the mechanism of action of BNT162B2 vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine was given (10 days in this case). However, a causal relationship between event "tested positive with Covid " (coded to Drug ineffective / COVID-19) and BNT162B2 vaccine cannot be completely excluded.

C/O "TINGLING PIN PRICKS" WITH SLIGHT ITCHING SENSATION, NO SOB, NO HEADACHES B/P 136/100 SYMPTOMS SUBSIDED 10 MIN. LATER

12:54 pm Pt reported feeling cold & feeling of throat closing. Pt calm & talkative through situation. Interpreter RN assisted with interpreting. Another RN assessed pt, negative wheezing &/or stridor, pt accepted bottle of water ingested/tolerated sips of water. Pt ambulated with RN w/o issue to have IM Benadryl 50 mg Right gluteus. Pt tolerated well. Pt prior hx allergies to PCN & NSAID?s w/side effects of laryngeal edema. 12:55 pm called over to pt, RN for 61 yo F with hx of laryngeal edema with PCN & NSAID?s. Pt states her throat feels scratchy, primary Spanish speaking w/interpreter at side. Assess pt no ins/exp wheezing. No stridor, no SOB on O/A 98% O2 sat, HR 67, with 90 SBP palp. Pt also, hx of anxiety. Pt given bottle of water with sips occasional clearing throat. No mouth/oral swelling visualized, however pt is requesting Benadryl. Pt does not have Benadryl on her & discussed with option of IM injection if pt feels she needs it. Pt not flushing, talking with staff & continues with no stridor. Pt again states she would like to have Benadryl. 1300 Per standing order with pt?s stated feels like her throat is having swelling/itching Benadryl 50 mg IM R gluteal with band aid applied. 1305 Per adm ALS called for f/u, pt continues with no distress, no stridor, no ins/exp wheezing. Pt sips on water & is talking with staff without distress. 1308 ALS on scene with update status, PMH & allergies with Benadryl 50 mg given @ 1300 IM, HR 67, O2 sat 98% RH, B/P 161/80 RA. Pt not in distress & is stating she feels much better, no throat swelling, just feels sleepy. Pt has husband in personal vehicle to assist pt home. Pt denies need for transport. 1323 Pt sitting in chair, calm & no distress, cont. to re-assess. 1330 Pt tolerated well & cleared for discharge to home with husband. Pt I/S to f/u with PCP if needed. Any SOB, increased anxiety d/t possible reaction, call 911 & will be re-evaluated. Pt consents to go home with husband driving.

Redness numbness and tingling in both hands Increases when hands are pointed down improves when lifted above the heart Is lessening but is clearly not listed as a side effect It is improving however is concerning more information and direction needs to be addressed several other coworkers have experienced or went to the ED with the same adverse effect. It is clearly not life threatening but I hope it will not increase with the second dose or continue in the future

Mild headache that evening, arm slightly sore during the night and the next day. Frontal headache and muscle aches the next day on 1/22/21. Some fatigue and nasal congestion that next day as well. Some fatigue and headache on 1/23/21. Took Tylenol once on 1/22 and 1/23.

Pfizer-BioNTech COVID-19 Vaccine EUA Approximately 3 mins after vaccination, pt reports nausea, dizziness, chest pressure, and profound weakness. Brought to Emergency Department by crisis RN where she remains achy with weakness, fatigue and had no energy. Pt reports "feeling tired" and "my speech is slower". On exam, slight R facial droop noted, tongue noted to be leaning towards the right, pronator drift noted in R arm. Code Brain activated with real time audio video interaction. MRI completed with normal results. Symptoms resolved. Stroke team ok with discharge to home with f/u with PCP.

sore throat; had chills; hot with a slight fever; hot with a slight fever; dizzy; tired/slept all day; congestion; severe headache; severe cough; achy/was in such pain all over; This is a spontaneous report from a contactable healthcare professional (patient). A 61-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL3249, expiration date unspecified), intramuscular on 18Jan2021 12:00 at single dose (left arm) for COVID-19 immunization. Medical history included slight hypertension and allergies to penicillin. The patient was not pregnant at the time of vaccination. Concomitant medication included losartan. The patient took first dose of bnt162b2 on 28Dec2020, at 10:00 (lot EL1284) at left arm for COVID-19 immunization. When the patient went to bed that night about 10 hours after the shot, I was just achy on 18Jan2021, at 22:30. When she got up at 02:30, she was in such pain all over and had chills and was hot with a slight fever, was dizzy, and tired on 19Jan2021. When she woke up later and had to call off, she had all of that (worsening), plus congestion and severe headache on 19Jan2021. The patient slept all day, but developed a severe cough by that night and she took nighttime cold medication to sleep and when she woke up on Wednesday, she took the daytime ones. The patient reported that she still have achiness, was tired, and a sore throat and some cough on Thursday, 21Jan2021. The patient received therapy for the event severe cough; and patient did not received treatment for the rest of events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. Outcome of events was recovering.

I am not sure this is what i shoud be filling out - just wanted to report what seemed like pretty bad symptoms on first dose by all info i have found. The actual shot was given by another facility than listed previously. I recieved the first dose of Pfizer at Health Dept . No other location information was provided by them. When i got the shot, a blood vein and possibly a nerve was hit. The nurse did everything properly i think to correct and notify other RN. It caused immediate pain in left fingers and arm felt heavy. That continued for days, but not too bad and injection site itself really was not very sore. My concern was how sick I felt starting within 6 hours of the injection and how long it lasted. I had pretty much instant nausea- no vomiting- mild but persistant, severe fatigue and general overall uneasy/sick feeling. Joint pain started within the 6 hours, along with a few odd pains in neck and right abdomen. Was extremely chilled for hours, pretty bad tension /tight feeling headache, jittery feeling and foggy. I took a 500mg Tylenol about 8 hours after the shot, and it helped to relieve most symptoms to a degree that was nagging, but tolerable. I pretty much went through this for about the next 3 days and off/on to the 5th day

Patient began to have chest pains, SOB, feeling flushed and tingling down both arms. EMS began with heart monitor on patient. EKG WNL B./P 140/97, HR 57 o2 Sat 100 %Ambulance transported patient to Hospital.

She had significant fatigue the day after the injection along with a sore arm and intermittent headache. Starting about 72 hours after the vaccine she noticed a swollen lymph node at the base of her neck on the side of the injection. The lymph node, sore arm and intermittent headache are still present.

Tingling upper and lower extremities, tingling left lower lip and cheek, weird feeling in head. Symptoms started February 1 at 6 PM were intermittent until 6 AM February 4. No symptoms until 6 AM February 6, again they were intermittent. Virtual visit with nurse practitioner at MD office February 6 at 11 AM. No symptoms since 6 AM on February 6.

arm pain; This is a spontaneous report from a contactable Health Professional. A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 13Jan2021 (at the age of 61-years) as a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced arm pain from vaccination on an unspecified date. The clinical outcome of the event was unknown.

facial flushing for 1 hour after shot. Redness on nose and cheeks for about an hour. No hives, no itching. Didn't notice until I left the vaccine site and was on the way home in car because covered by mask. Note I am a very fair skin, freckled red haired woman. I was very, very nervous and had gotten myself to the point of tears. Perhaps the flushing was from that. Have had similar flushing when drinking red wine. Swelling in lymph node in supraclavicular area on same side as shot. Has happened with Flu shot once. Slight fever for a short period of time and fatigue. I continue to have slight shortness of breath from having covid on. 4/3/20. Nothing different.

Feeling like I'm being pricked from the waist down. It's in varying spots and doesn't last long in any one spot. Assuming this is a nerve reaction.

Initially after injection I felt as if a rapid heart beat (but 60 minute pulse count was no more than 80 and was regular). Discomfort in arm began, progressed to inflammation and difficulty in movement of arm especially to lift arm. Used Tylenol or Motrin PRN for relief as well as heating pad intermittently. After 1/23 injection discomfort seemed to lessen but on 2/9 (4 days before second injection due) discomfort still persists. Due to persistence of symptoms seen in Urgent Care diagnosis Adhesive Capsulitis of right shoulder and acute pain of right shoulder. Treatment, Physical Therapy and Ibuprofen. Unable to use steroids due to diabetes. Follow up scheduled 2 weeks 2/16/2021.

Patient described having a "mild reaction" to first dose Pfizer BioNTech vaccine, and pre-mediated with 50 mg diphenhydramine as well as her morning cetirizine 10 mg before the second dose. Approximately 10 minutes s/p second dose the patient experienced dizziness, facial tingling, anxiety, hard and soft palate numbness, and flushing. She was helped to a stretcher and her BP was 204/94. The patient was taken to the ED for further monitoring. In the ED, she denied any throat swelling, tongue swelling, or difficulty breathing on arrival. She also denied any chest pain and palpitations. She received methylprednisolone 125 mg IV x 1 and a liter of normal saline, underwent observation, then discharged home uneventfully.

30 minutes after injection: severe headache, general feeling of illness. Following day in the morning, headache, left arm in extreme pain, facial numbness, disorientation, inability to talk, confusion, difficulty breathing

Headache; cramps; Woke up feeling terrible; Over all body ache; Like no energy; This is a spontaneous report from contactable Pharmacist (patient). A 61-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)Lot number EL1284, expiration date 30Apr2021, Intramuscular on 13Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were none. The patient previously received first dose of BNT162B2 on unknown date. The patient received her second dose of the Pfizer vaccine a week ago on Wednesday, '2 days ago' (not clarified), so it's 9 days ago and she was wondering if she could still have, she felt fine for over a week and then yesterday (22Jan2021) she woke up feeling terrible, just over all body ache, 'cramps' (voice feeble not clarified further) like no energy and she was wondering that. She was getting a headache now from this conversation. She did take Acetaminophen yesterday and she was ready to take it now, that's a bad headache. The outcome of all events was unknown.

I am a teacher, so thankful to have received my vaccines. 40 years ago, as a young teacher I had a bad reaction to a flu shot and I have never had another one. I didn't think this vaccine would be similar. I am not someone who gets very sick often and I don't miss days of teaching for illness. Note that my first vaccine on 1/21 had no effects. I did not even get a sore arm. I even sort of bragged about it. The 2nd vaccine on 2/11 seemed fine until I woke up the following morning feeling like I had been hit by a truck. I yawned for 3 hours straight, but still made it to school and worked and taught 6 online classes. I took an ibuprofen that morning because I was feeling so odd. By 3:00 I was driving home (40 minute drive) and I cried uncontrollably the whole way home while my hands and feet were shaking. Not normal for me. When home I went almost immediately to bed. I had a slight temperature and was dizzy. I thought I had the chills but it didn't feel like any chills I have had before. Usually my teeth would chatter and I would feel hot and cold at the same time. The hottest temperature I had was 100.5. But by 9 I started shaking so profusely that I couldn't pick up the thermometer any more, I couldn't use my phone, or take a sip of water. I stumbled to the bathroom holding onto things all the way. My husband was not home, or I imagine he would have called 911 at that point. I kept shaking a lot through the night and kept praying that it wouldn't happen to my heart. I fell asleep eventually and dreamed of fish flopping inside me and my neighbors coming over to to see why the bed was knocking against the wall. Saturday morning I woke up and all the shaking had stopped, but I found I was too weak to get up much. Today is Monday and I mostly feel normal, except a little dizzy when I move and the top of my head is tender to the touch.

On February 4, 2021, I started to itch and feel like pins were sticking me on the front of my neck under my chin. On February 5, 2021 I started taking benedryl 25mg to combat the itching. By February 8, I had a fine rash, small raised all around my neck and very itchy and again I took benadryl without improvement. Benadryl would have a short term effect and just made me sleepy. This continued for 3 more days until February 15 when I was able to see my doctor who has now listed me as having a reaction and allergic to the Covid 19 Vaccine. I am prescribed topical steroid cream and hopefully it will improve.

Patient felt moderate hand pain following injection. was evaluated by clinician on site and instructed to take routine pain medication once patient was home.

Severe all arm pain for short period of time, chills, headache, fatigue, swollen lymph nodes and continuing nausea.

Severe migraine headache with pain behind eyes with uncontrolled tearing, ringing in head, pain and pressure lasting about 12 hours. No treatment. Dull headache with numb forehead lasting several days. Took Advil for 3 days Wheezing and shortness of breath lasting 6 hours and the same symptoms the following day lasting about 6 hours. No treatment Did call the doctor with my reaction and concerns for second dose recommendation.

Left thumb and all the way to the wrist sore, inflammation, very painful, sore, tender, stiff. on a scale of 1 to 10 on pain, it is an 8. Keep thinking it will get better each day but it is not getting better.

61 yo F with history of bilateral lung transplant 6/23/17 presented to ED on 2/4/21 with chief complaint of worsening shortness of breath, nausea and diarrhea for past week since receiving since receiving COVID-19 vaccine (Pfizer) on 1/28/21. Upon arrival to triage she was obviously dyspneic with significantly low oxygen saturations. O2 sats on arrival were 65%, improved to mid 90's with O2 6 liters per NC. Admitting diagnosis: hypoxic respiratory failure post COVID vaccine. Lab work shows an elevation of the BUN and creatinine at 31 and 1.71 which is slightly higher than her usual baseline levels. BNP is elevated at 2 448 with a mildly elevated troponin. Procalcitonin is also elevated. Patient's white blood cell count is 11.07. Full viral panel including COVID-19 is not detected. All blood cultures and respiratory cultures were negative. Patient chest x-ray shows numerous bilateral patchy opacities which is significantly different from her previous chest x-ray here. Empiric rejection treatment initiated including high dose methylprednisolone, plasmapheresis, IVIG, Thymoglobulin. She continued to decline and ultimately required intubation, proning and paralyzing on 2/8/2021 and then VV ECMO cannulation on 2/13/2021. EGD done 2/14/2021 as unable to pass the TEE probe during cannulation prior day (unable to complete due to abnormal anatomy). Acute pupil exam change in the early am hours of 2/15/2021 prompted urgent head CT which revealed catastrophic brain bleed. Brainstem reflexes were lost soon after. Despite placing an EVD emergently at bedside, brain stem reflexes were not recovered. GOL engaged and patient not an organ donation candidate. Therefore discussion with sister at bedside resulted in decision for cessation of life support. Patient expired shortly after support withdrawn and pronounced dead on 2/15/2021 at 11:11 AM.

Mouth and tongue (top and bottom) numb and stinging, facial swelling and red rash - 5 days Fever 101 - 2 days headache - 5 days nausea - still have diarrhea - 6 days Sore and stinging left arm (received vaccine), sore upper and lower back and neck. Felt like I was kicked in those areas - still have Fatigue - 6 days, lessening Toes bright red at the top and are painful, areas on bottom of toe as well - still have

Sore arm started about 6 hours after the vaccination and lasting about 24 hours. Fever, chills, severe body aches, severe headache lasting about 9 hours starting at midnight following the vaccination.

The right side of my face has gone numb as if I had a dentist's injection. Started the same evening as the vaccination. Includes even the ear.

almost like she also had some mild hearing loss; nausea; exacerbation of migraine with paresthesia and tinnitus/ headaches/migraines; exacerbation of migraine with paresthesia and tinnitus; exacerbation of migraine with paresthesia and tinnitus/ increased tinnitus; some abdominal tightness; This is a spontaneous report from a contactable pharmacist (patient herself) via Medical Information team. A 61-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL3302, NDC number/expiration date was unknown), via an unspecified route of administration on the left arm (also reported as upper left arm) on 13Jan2021 at 09:00 at a single dose for COVID-19 immunization; the patient was a healthcare worker and was trying to protect herself. The vaccination facility type was reported as a drive thru site. Relevant medical history included previous neurological problems, which included history of underlying migraine with paresthesia/chronic paresthesia (ongoing) and tinnitus. The patient had no family medical history relevant to the adverse events (AEs). There were no concomitant medications. The patient had no other vaccine received on the same day of the Pfizer suspect or 4 weeks prior. She never had any problems with vaccines in the past. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. Initially, the patient was asking if there were any reports of paresthesia, serious neurologic adverse events, tinnitus, hearing loss, or abdominal tightness in the studies for the Pfizer-Biontech Covid-19 vaccine. After the patient received the first dose of the Pfizer-BioNTech COVID-19 vaccine on 13Jan2021, she experienced an exacerbation of migraine with paresthesia and tinnitus. She also reported experiencing some abdominal tightness on an unspecified date in Jan2021. The patient reported she was scheduled for her second dose of the Pfizer COVID-19 vaccine, but had concerns because she was still experiencing tinnitus and it was "almost like she also had some mild hearing loss" on an unspecified date. The patient further reported that she was due for the next dose the following day at the time of the report (03Feb2021). She had previous neurological problems and did not know if this did exacerbate things or not. She had migraines, tinnitus, and paresthesia and was wondering how many other patients with neurological problems reported this and was this a common side effect or adverse event reported. One doctor told her not to get the second dose and another one told her to get it and she wanted to know what she should do. The patient had headaches/migraines on the evening of vaccination on 13Jan2021 that were fairly mild and 3 days after that on 16Jan2021, they got bad and was accompanied with nausea with increased tinnitus. The migraines and nausea had gone, and the chronic paresthesia was the same as she always had, but the tinnitus was a lot louder and worse. The patient also mentioned that her migraines usually go away, but this one had lingered. The AEs did not require any visit to an emergency room or a physician office. There were no investigation assessment. The patient recovered from the event "nausea" on an unspecified date, she was recovering from the event "exacerbation of migraine/ headaches/migraines," she was not recovered from the events "exacerbation of paresthesia and tinnitus/increased tinnitus, while the outcome of the events "almost like she also had some mild hearing loss and some abdominal tightness" was unknown. The reporter assessed the events "migraine, tinnitus, paresthesia, and nausea" as serious, other medically important conditions. The relatedness of drug to the reactions/events "migraine, tinnitus, paresthesia, and nausea" was unknown as per the reporting pharmacist (Method of assessment: Global Introspection).; Sender's Comments: The 61-year-old female had relevant medical history included previous neurological problems. The reported neurological events and partial hearing loss were more likely due to pre-existing conditions, and less likely related to the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE). Event nausea was likely due to the first dose of bnt162b2. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.

This is a spontaneous report from a contactable pharmacist. A non-pregnant (not pregnant at the time of vaccination) 61-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EN5318), intramuscular, first dose on 23Jan2021 09:45 at single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was seated in observation area for a 30 minute observation after injection of COVID-19 vaccine on 23Jan2021 09:45. At 10:00, after 5-10 minutes stated she had tingling to tongue and lips. Shaking noted to hands and patient stated she felt numbness to upper extremities with dizziness then felt light headed. Patient transported to first aid room for further assessment and observation. Patient was alert and oriented (A&O) x4, lungs clear to auscultation. Patient also stated she felt like she needed to take a "deep breath". Patient had O2Sat of 95% on room air (RA) and blood pressure (B/p) of 130/80. At 10:16, physician ordered to give patient 12.5mg of diphenhydramine (BENADRYL) liquid oral 1 dose with 16oz of water intake during observation period. Patient was continuously monitored and noted that was able to ambulate at 10:25 to bathroom with assistance but still experiencing dizziness. Patient was monitored for a total of 45 minutes then discharged home. Facility where the most recent COVID-19 vaccine was administered was at a public health clinic/veterans administration facility. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on 23Jan2021 10:30. Case was reported as non-serious.

Around 1 am on 1/29/2021, hot flashes, fever 99, & a little bit nauseas this lasted 48hrs. My legs felt weak & shaky legs and fuzzy head. I feel with no energy. This symptoms are still going on.

Patient got up from being in bed in the AM and noticed some numbness/tingling in bilateral extremities. There was concern for stroke so the patient came to the ER .The patient had received the second dose of the Pfizer vaccination 2 days prior. The patient received tPA and was treated in the ICU. After a short hospital course, the patient was discharged home.

Thursday February 4th I had Severe Headache, Earache, low grade temp, sore throat then by the Tuesday the 9th I noticed drooping to the right side of my face. Went to the ER and was told it was bells palsy

Pt with marked hoarseness, SOB, & Wheezing. O2 sat 89%, O2 applied. Benadryl 25mg given PO, Solumedrol 125mg given IM, Epi pen administered x2 doses. Transported via ambulance to hospital.

Sharp arm pain down arm of shot. Within 20 minutes of shot experienced moderately severe vertigo and dizziness, along with difficulty breathing normally.

patient reported: Mild headache after the vaccine, Headache resolved after 1-2 d After 2 days of vaccine she started feeling right leg heaviness (whole leg) , she was dragging when she walks But no visible swelling, pain, redness per patient, She states at that time she was able to stand and move leg fine but only when she walks she needed to drag No facial weakness , upper extremities symptoms . Had slurry speech intermittent for 1 week after vaccine (Currently none) Lasted for 2 weeks, then resolved completely. after that no symptoms at all. Now Waking fine, no facial weakness, no extremities weakness She did not call us at that time as she thought it is side effect of covid vaccine and thought it would go away. When she went for covid vaccine #2, they said she needs to contact primary care physician due to some symptoms after first vaccine,. then she called us for an advise. by the time she called, no symptoms of neurology. MRI brain: did not show any abnormalities Discussed with local Infectious disease specialist: not sure those were vaccine related or not, recommended to report.

Right side upper arm ache spread to right side of neck and into headache at back and top of skull. Persisted through night and spread down into right side of neck to left arm ache. Throat became red and right, then left side of tonsil became pus filled. Chills but no fever. Fatigue every day. Took 2-3 hour naps every couple of days and slept 8-10 hours through the nights. Headache off and on for 10 days. Throat remained red, becoming most sore late afternoons, voice hoarse. On and off drippy nose. On the 13th day I felt normal energy level in the morning but today, my 15th day at nearly 3pm, my normal energy is waning and throat becoming sore again.

Extreme lower stomach pain; Could not move for 3 days; dehydration; fatigue; speech issues; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration (anatomical location/vaccination location: arm left) on 29Jan2021 13:30 at SINGLE DOSE for COVID-19 immunisation. Medical history included bad back, penicillin allergy, and covid prior vaccination all from unknown dates and unknown if ongoing. The patient has not had other vaccine in four weeks. Patient was not pregnant. Concomitant medication included oxycodone hydrochloride (OXYCONTIN). The patient experienced extreme lower stomach pain, could not move for 3 days, dehydration, fatigue, and speech issues (all events assessed as serious - disability) all on 05Feb2021 17:00. Patient's clinical course is as follows: One week after the shot, patient had extreme lower stomach pain, could not move for 3 days, dehydration, fatigue, and speech issues then continued for 2 more days. No treatment was provided for the events. It was reported that patient was COVID tested post vaccination. The patient underwent lab tests and procedures which included nasal swab with result of negative on 20Jan2021. Facility type vaccine was reported as nursing home. Outcome of the events was recovering. Information on the lot/batch number has been requested.

Loss of use right leg. Paralysis, numbness, tingling, severe pain, and muscle spasms. Acute onset without other trauma

Pain on right-side of back all the way to front of chest and under breast and part of right shoulder. Week prior felt sensation of "pins and needles" on back. Patient reports 1 blister spot on chest. Patient went to urgent care and was diagnosed with shingles. Doctor prescribed Valtrex and Ibuprofen.

chills, fever 3-4 hours after vaccine administration injection site pain: took Tylenol 1200mg, helped. Limited range of motion noted on L arm, could not lift arm ROM more than 30 degrees 12 hours after vaccine still had chills, and fever. Then started to itching on both hands, noticed and uncontrollable itching. Took Benadryl 25mg and feel asleep. hives and itching was gone by the time she woke up. Severe fever and body aches 22 hours after vaccine administration. Temperature was 101.8. Throat felt "sore, with some little difficulty swallowing", took Tylenol 1200mg and Vit C 2000mg and Vit D 10,000 IU and Zinc 100mg. Today, 48 hours after vaccine administration, having systemic hives, and eyes are puffy and swollen, R eye more than left, upper lid is swollen. Took Claritin 10mg and Famotidine 20mg. Hives are better but not fully resolved, but itching is persistent. Still discomfort noted in swallowing.

In the morning of Thursday February 25 at around 6:5 AM, as I was brushing my teeth, the water was leaking out when swishing from side to side. As the day progress, the right side of my mouth was getting number. The next morning Friday February 26, the right side of my face was numb, my speech was swirl, eating and drinking became challenging. I went to the emergency rom at Hospital where the team of doctors diagnosed me with Bell's Palsy. I was given Prednisone and Valtrex for a period of 7 days. Physical therapy as also being advised. The hospital advise me to follow up with my Primary Care Doctor (schedule for Monday March 1st), and to see a neurologist (waiting for an appt). As of today, the right side of my face has lost mobility.

Client states that she has weakness, body aches, and dizziness since vaccine. Continues to have these symptoms

arm/joint pain, vomiting chills low grade fever overnight, headache. Severe pain in shoulders, hips and lower back lasted 3 days. lymph nodes in armpits very sore. headache lasted 2 days. vomiting lasted 8 hrs. fever(99-101) lasted 2 days. had 3 minor breathing incidents which was alleviated by using rescue inhaler(albuterol) Called in to Health Service and messaged primary care, was advised to take advil, tylenol, lots fluids and get tested for COVID19.

Severe neck soreness and tenderness 2/27 & 28, took Tylenol Rash& Itching at injection area. 2/27 4:00pm. Itching stopped 2/28 however the rash is still present on 3/2. Took Benadryl.

The next day, when I woke up I was unable to stand on my left leg. Pain in the posterior knee. Felt like I was walking through mud. Joints were all loose. Just a really bad left knee pain. They a lower extremity doppler to that leg - to look for blood clot and that was negative. Physical therapy - taped my knee; pain was so bad I had to stay home a couple of times. My hands (both) were so painful. Like I had frostbite. Occupational therapy did hand massage and paraffin for the pain. And isotoner glove at night and that helps with the buzzing. I am 2 months out today from the vaccine and I'm starting to feel like normal. Took two months to fade away. It may have been because I was still having COVID antibodies. COVID antibodies on August started at 6.95. I'm not totally recovered right now but I'm close to normal. Doctor visit - January 29, 2021 and February 5, 2021.and February 19th. They put me on high dose of Steroids - 20 mgs Prednisone daily and another round of blood thinner -ELIQUIS mg which helped me with pain and joints.

mild persistent headache all symptoms are mild flushed face tired lack of appetite/ food tastes different rash

pt states that she developed a head ache, chills, fever and sore arm. Pt took Advil to alleviate the pain and her reaction lasted around 24 hours . The symptoms had subsided by 2 PM the next day.

rash on neck; felt a little off, it could have been in her head or maybe was paranoid, but wasn't going to wait for the reaction to be full blown over her body and took one Hydroxyzine HCL; developed a bad rash, hives, all over her body; developed a bad rash, hives, all over her body; itching; a few bumps kept increasing up to 3 days later; her feet were incredibly hot over the next 3 days; arm soreness; She was unable to sleep from being so itchy; Allergic reaction; This is a spontaneous report from a contactable consumer herself. A 61-year-old female patient received bnt162b2 (, Solution for injection, Batch/lot no: EN5318), via an unspecified route of administration on 04Feb2021 15:00 in the left arm at single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously did get a flu shot in Nov or Dec2020. The patient developed a bad rash, hives, all over her body and itching on 10Feb2021. She reports, her feet were incredibly hot over the next 3 days on 07Feb2021. What started off as a few bumps kept increasing up to 3 days later. She was unable to sleep from being so itchy. Her doctor said it was an allergic reaction and prescribed an antihistamine after which it left in Feb2021. She was due for the 2nd dose of the vaccine on 25Feb2021. The patient did not had any investigation assessment. The patient states that there was little information out there to compare the experience she had. Wanted to call to make Pfizer aware of that and maybe get some more information out there. Has printed out the fact sheet and assumes she should not get the second vaccine because of what happened the first time. Wants to clarify what happened and share with Pfizer this information since she can't find much information for people who have had a delayed reaction. Went to get the vaccine on 04Feb and doesn't consider herself an allergic type person. Has no allergy to foods, medicines, only gets poison ivy and bug bites like most people. By Monday, the 4th day (08Feb2021) after getting the vaccine, noticed a couple of bumps on the wrist and does not know where else and didn't think of it as anything else. Thought it was a bite or she touched a plant and then it went away. It was not much. In the evening of Tuesday she had a bad reaction and on the 10th (10Feb2021) she had rash, hives, and itching that just moved to different places over the body. Her feet were so hot on the 3rd day and had to plunged them into cold water and used Epsom salt off and on and it helped some. This happened only for 2 nights and the reason she didn't go to the doctor, it went away. Again, mentions the first night she had a couple bumps and didn't think much about it. The second night, it was all over her body, the rash, and she took Epsom baths that helped, but she didn't get much more than an hour of sleep. She tried to take pictures of her thighs and backside, but unable to take good pictures, not a selfie person. The next morning she had her husband take pictures in case it went away and she went to the doctor they would have pictures to show. Her husband thought it may be shingles. Called the doctor on Thursday and had pictures to show her since the rash went away. Again, mentions the reaction was so bad on Wednesday. The doctor didn't believe areas on pictures of her back were shingles since shingles does not come and go away like that and that she must have had an allergic reaction to something. Provider didn't believe it was from the vaccine. Was given a prescription for Hydroxyzine HCL 25mg and was informed if areas didn't improve or returned she may need to see an allergist or immunologist. After the appointment she didn't get much sleep and woke up at 4pm in the afternoon and felt a little off, it could have been in her head or maybe she was paranoid, but she wasn't going to wait for the reaction to be full blown over her body and took one Hydroxyzine HCL and went to bed at 7:30pm and didn't do anything since. Got up and the reaction/rash, hives, itching was all gone after taking only one. It's like an antihistamine or Zyrtec. No further details provided. Later mentions after getting the first vaccine on the 4th, the next day she had arm soreness up until that Monday when the rash started. No further details provided. Says as far as recommendations were concerned for the paper she printed, the fact sheet. It says pretty much listed, she shouldn't have the second dose if difficulty breathing, swelling in the face and throat. The only thing she had was the rash on the neck, not the face. Paperwork also lists heart beating fast, or severe allergic reaction. The patient had no emergency room visit. The patient visited the physician office. The outcome of the event hot feeling in feet was recovered on feb2021 and rest of the events was recovering.

shortness of breath, tingling feeling in lip and face; shortness of breath, tingling feeling in lip and face; shortness of breath, tingling feeling in lip and face; This is a spontaneous report from a contactable other healthcare professional (HCP) who reported for herself. A 61-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) intramuscularly on 20Jan2021 at 14:45 (at the age of 61-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included restless leg syndrome from an unspecified date and unspecified if ongoing. It was unknown whether the patient was diagnosed with COVID-19 prior to vaccination. Concomitant medications (received within 2 weeks of vaccination) included tretinoin (RETIN A; skin cream), biotin, vitamin D NOS, calcium and multivitamin, all taken for unspecified indications on unspecified dates. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient experienced shortness of breath, tingling feeling in lip and face, all on 20Jan2021, all reported as non-serious. The events did not cause hospitalization. No treatment was received for the events. The clinical outcomes of the events shortness of breath, tingling feeling in lip and face were all unknown. It was also reported that since the vaccination the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Pt s/sx started at 1200. Pt c/o stomach pain 4/10 on pain scale, throbbing pain in the L arm and needing to vomit. Pt denied chest pain, difficulty breathing, and difficulty swallowing. Pt denied any similar reaction to vaccines. Pt stated that she had not eaten anything that day. Pt was offered EMS. Pt refused EMS. Pt was offered an adult dose of diphenhydramine. Pt agreed to take medication. First dose administered at 1222 by RN, second dose administered by RN at 1223. Pt stated at 1250 "I feel like I need to puke." Pt was offered EMS for a second time. Pt refused EMS. Pt left vaccination site with son at 1305 with a steady gait.

Slurred Speech, fever, aches, feet and hand swelling, confusion, headache, memory loss - mostly resolved some memory issues and headache still 2 days later

Immediately after I got the shot, My nose started running and. Lips felt big and tingling. ( MD did not see visible swelling). And roof of mouth was numb, throat felt like it was closing up, Started getting hoarse, chest tightening. MD gave me 25mg Benadryl and after 30 minutes starting relaxing, Coughing up phlegm. My left arm was very sore and swollen like a lemon... Today. My lip feels kind of burning (like pre herpes outbreak). and roof of my my mouth is still numb. I noticed that I lost sense of taste completely!

I had 2 minutes left from waiting my 15 min after receiving my first vaccine and all the sudden I got very flushed/hot. And then light headed. It lasted about 5 minutes and I ended up staying an extra 30 more minutes. Then I was fine. No other problems.

I have neuropathy symptoms, sore joints and muscles believed due to Tacrolimus. I see a neurologist later this month. Following the first Covid vaccine, these symptoms increased. I was unsure whether this increase was due to the vaccine. However, following the second vaccine, my symptoms increased again and are substantially more severe than they were prior to the vaccine. I am also having increased pain in the area of my liver following both doses.

On day 2, I developed confusion and could not focus making it impossible for me to complete my work at my job. The confusion made driving dangerous. By Friday, I went to my PCP and they noticed that my blood pressure was only 90/58 and they were concerned so she told me that she was calling my cardiologist who said to reduce the dose of my Diltiazem from 180 mg daily to 120 mg daily. She also said to take a few days off of taking the Diltiazem. I have also had a serious increase in Tachycardia. That evening I went to the ED because I was so weak and couldn't breath well. I am also retaining a lot of fluid. The lab work indicated an elevated Pro-B-Natriuretic Peptide level of 227. I am still not well and each doctor I have spoken to said they believe it is due to the vaccine. I do not know if I should take the second dose.

With in an hr. my left thigh muscle hurt and my left knee was starting to stiffen up. In 2 hrs., varicose vein in left thigh was extremely throbbing, I could barely walk on stiff knee. I had a trouble night of pain on Sunday 2-28, Monday , I could barely walk on left leg & still had thigh pain, I almost fell down stairs 2x from leg buckling, I did fall down in the kitchen and the fam. room from knee buckling, not supporting my body. I used heat, ice, rest, ibupfen, advil, tynelol, ben-gay, icyhot, CBD cream. I used it all. Today is one week and the thigh pain is gone but knee is still stiff. It no longer buckles, but I still can not fully walk. I am using a cane. I have been working from home all week, but can not cook for myself. I have to sit in a chair in the shower. I did contact my Dr., who said keep doing everything I am doing, that as long as it getting better every day. I am afraid to take 2nd dose.

I felt a shooting pain immediately from my arm into my shoulder area, and then felt itching and had a slight rash on chest area. When checked to be released, upon mentioning the rash, they checked my blood pressure, which is normally in the 90-100/68-70 range (low!) and it was 138/80. Sounds normal, but I?ve never had a blood pressure reading that high! I felt ok enough to leave with my husband, but later got dizzy, nauseous and throughout the day my joints (neck, shoulders, arms and legs) got increasingly painful, to the point where I could barely climb the stairs that night without assistance. Note: I run 5K every other day and bike or walk on off days, so I?m pretty active. I took Tylenol and went to bed early and was stiff, but better the next morning. Made myself get outside for a light run and was basically fine (albeit very tired) the next day. First day was a little scary though.

Rapid heartbeat, flushing, tingling of whole body like an adrenaline rush, felt like my blood was on fire. Hoarse voice and constant clearing of throat due to production of phlegm in throat. Tingling lips and tongue. This continued all day until I took 10 mg of prednisone. Within 3 hours, all symptoms were gone. Slept well all night. The next day (Wednesday) I felt fine. Slept fine Wednesday night. Thursday morning, all of the above symptoms returned. I took 5 mg prednisone, which didn?t alleviate symptoms so I took an additional 5 mg. I also took 2 Benadryl. Symptoms went away. Slept well Thursday night. Friday morning they returned. I had a doctor?s appointment scheduled (new patient visit) which I canceled as the office told me to go to the ER at the hospital where I got my shot. By the time I got to the ER, my symptoms had subsided. The ER doctor gave me 60 mg of prednisone, 1 famotidine, Benadryl.

Headache; Arm sore; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients (reporter and reporter's husband). This is the first of two reports. A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9269 and expiry date: unknown),via an unspecified route of administration on 04Feb2021 at a single dose for COVID-19 immunization. Medical history included diabetic and high blood pressure. Concomitant medication included metformin and, hydrochlorothiazide, losartan potassium (HYZAAR). Patient got the vaccine on 04Feb2021, last Thursday and the effects have not been bad, it was just arm sore on the same day. She did not have any headache but yesterday on 06Feb20021, she had a headache. No treatment was received for the events. The second dose was scheduled on 25Feb2021. Outcome of the events was recovered on Feb2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021174383 same reporter, vaccine, different patient and event

Patient received vaccination at 12:10. At 12:25, patient complained of tongue thickness. EMS called. Difficulty breathing. Developed seizures. Epinephrine 0.3 administered. Seizures continued on/off for approximately 1234. Tongue swelling did improve. Transferred to hospital setting via EMS at 1245.

After 1st dose : Fatigue/tiredness/lack of energy for 1 day. After 2nd dose: Fever of 101 - 102.6 for 3 days. Hips achy. I have a total knee replacement of my R knee. That became warm to touch, painful and very stiff. The knee surgery was 3 years ago. I was prescribed MOBIC for the knee by my surgeon when I reported the issue.

Dizziness at 5 to ten minutes of injection , elevated blood pressure. Dizziness was improving after 30 minutes so I was allowed to leave the vaccination facility shortness of Breath started 35 o 40 minutes after injection. When I was was walking out to my car My daughter was in area and picked me up and she had Benadryl Took 2 Benadryl Shortness of breath started to improve after An hour of Benadryl. Hoarse voice improved some but continued to improve after second dose of Benadryl. Now on March 11 I still have a slight hoarse voice but so much better. I?ve been taking Benadryl every 4 to 6 hours regularly per my Dr I don?t have shortness of breath anymore but my chest does feel a little tight

I am on infusion for severe psoriatic arthritis, and was doing well. Two days after injection it was as if the effects of my infusions were cancelled. Extreme widespread stiffness, pain, joint swelling and heat, muscle weakness and pain. I also had swollen lower lip and have had an increase in headaches and nausea. Two weeks after the injection I awoke with my right arm swollen, hard, and itchy. The arm and my lips have resolved, but I am still having all the other problems. I have reported these symptoms to both my primary doctor and my rheumatologist.

Slight headache and moderate arm pain ; both arm pain and headache gone by next morning; this is for reporting purposes only; no care needed; all side effects abated in a reasonable time period.

Third and fourth fingers of left hand (vaccination arm) went completely numb for 2 hours. Massaged for 2 hours and numbness changed to tingling for another 10 hours. Within 24 hours of vaccination time symptoms cleared.

Already described people - excruciating pain in my right shoulder arm & elbow causing nausea. Shot given in left arm. I?m at home so far nothing dead or hospitalized thank you

February 25, 2021 approximately 9:30 am: Approximately 5 minutes after receiving vaccine had a strong medicine taste in throat. Lasted 45 minutes - 1 hour. Approximately 9:55 am slight feeling of throat closing, which lasted about 45 minutes. Approximately 10:00 am headache, which lasted until approximately 4:00 pm, February 26, 2021. Arm soreness evening of February 25, 2021 lasted approximately 2 weeks. February 26, 2021 approximately 6:00 am diarrhea, headache, chills, legs aching, and fatigue, which lasted until until approximately 4:00 pm.

Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium

Metallic taste in mouth that subsided the next morning. Sore arm for 3 days Slightly feverish on and off for the first 2 days All of the above were relatively mild

Mild tingling and numbness on right side of face beginning 25 to 30 minutes after getting the vaccine. Right eye began watering later in day. Noticed watering eye after taking 1/2 of a 10mg Zyrtec that evening. This morning, 3/14/2021, the watering right eye continues and the numbness and tingling in right right side of lips continue. The symptom to rest of right side of face appears to have dissipated. The best way to describe it is the feeling to face and lips is it feels similar to the feeling when Novocaine is wearing off.

8 days after vaccine, developed burning sensation of skin which has changed locations in upper and lower extremities. Lasts hours at a time and changes location. Also developed diarrhea, vomiting, body aches, chills 8 days after the vaccine.

9:00 p.m extremely tired, no energy, head ache body aches. Cold chills then hot. Weak thru Monday 3/15/2021 feeling better , just still feeling tired.

Constriction of throat followed by heaviness in chest, followed by a headache. Had distress but was afraid to say something. hands tingling fingers both hands. NOT hyperventilating. Oriented but sluggish to respond to questions. initially elevated bp then hypotensive. after leaving vaccine clinic throat felt like a golf ball and went to ER to seek treatment. DX- allergic reaction and given IV Benadryl, Pepcid and solumedrol.

Friday evening I was tired and slept a lot. When I woke up on saturday I had pain in my muscles and neck and in my shoulders. I was not hungry and I had a fever(101.2). I slept until 1pm and I started getting nauseous. I never got up off the couch saturday. Pain in left arm/shoulder blade went away around 5pm Saturday. I still had a slight fever and headache saturday evening. Sunday I felt better but I still had a slight fever and headache but felt generally much better. Monday I had no fever no headache, and a little aching in my right arm at the injection site.

I haven't been able to walk nor stand without very sharp pain in my left lower side.I Been experiencing really bad spasms whenever i stand or sit down.

Paresthesia in lower legs bilaterally from mid calf to feet started 3d after second dose COVID vaccine.. symmetric. Neuro exam was neg.

Patient became sweaty, unresponsive, and felt dizzy. Patient was given orange juice and had her place her head between her legs to increase blood flow. EMS was called.

Sore left upper arm by 5pm, 3-13-21. Very tired, muscular aches whole body, chills/feverish, headache overnight to present, nausea. abdominal cramping and diarrhea x 2 days. Feels like 'the flu'.

3-10-21 7:15PM PT 'FEELING ANXIOUS, NUMB, DIZZY - IS DIETING AND IS TAKING ADIPEX. ONLY ATE TOAST TODAY AND 2 BITES OF CANDIES'. GIVEN JUICE AND CRACKERS. 7:25PM 'FEELS BETTER'. AMBULATORY TO EXIT WITHOUT DISTRESS. 3-11-21 9:30AM PT STATES 'FEELS 100% BETTER NOW'.

61 yo female admitted with palpitations and flushing since getting the Covid 19 Vaccine on 3/8.. She was prescribed metoprolol and a short course of steroids by her pcp for symptomatic relief which patient took 1 dose of metoprolol and did not start steroids. She came to the ED due to her symptoms, Her main concern was why did she react to the Vaccine., and wanted answers.

A 61 y.o. female who received the Pfizer-BioNtech Covid-19 Vaccine, mRNA, BNT162b2 (PF) 30 mcg/0.3 mL IM Susp, Lot ER2613 on 3/16/2021. The patient experienced the following reaction(s) during the immediate of observation: 11:42am Patient c/o "dizziness and mumbling noise." Patient alert, oriented, and verbal. Patient assessed in treatment area. Patient was treated/managed as follows: 11:44am VS BP 118/64, HR 67, RR 18, O2 sat 98% on room air. Patient denies shortness of breath or difficulty breathing. No swelling noted to face, mouth, or tongue. 11:59am VS BP 134/80, HR 70, RR 18, 97% on room air. Patient reports feeling better and symptoms have subsided. Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. 12:08pm Escorted to car by sister and RN.

Bi-lateral breast pain. I have not had much breast pain with my fibrocystic disease as I have gotten older but for 6 weeks after the second dose it felt as bad as it ever has. It kept me up at night and I had to take OTC pain relievers.

Fluid buildup in lungs. Than pneumonia set in.; Fluid buildup in lungs. Than pneumonia set in.; Weakness; lethargic; This is a spontaneous report from a contactable consumer. A 61-year-old female patient received BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 13Feb2021 (Lot Number: EN6200) as SINGLE DOSE for covid-19 immunization. The patient's medical history was not reported. Concomitant medication included oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) taken for an unspecified indication, start and stop date were not reported. The patient experienced fluid buildup in lungs. than pneumonia set in, weakness and lethargic on 15Feb2021. Therapeutic measures were taken as a result of all the events which includes Medicine and breathing treatments. Outcome of the events was recovering.

Patient received vaccine and remained in pharmacy for 15 min. She had no adverse effects during that period. She then got in her car to drive home and within 5 min (20 min after the vaccine) she began having numbness in her face. She then drove back to the pharmacy to notify us of this. She denied any chest tightness, swelling of lips/throat, difficulty breathing. She was given 25 mg diphenhydramine and remained under our observation for another 15 minutes. Symptoms improved within 10 min after administration of diphenhydramine and drinking a bottle of water.

Patient was sitting in monitoring area status post covid vaccine injection (Pfizer 0.3mL). Patient complained of flushing, erythema noted on anterior neck and chest, and hive was observed. Patient denied shortness of breath. BP 132/92, HR 90, Pulse ox 98% room air. Benadryl (Lot #080012, exp. 08/2022) was administered 50 mg/IM per order into left deltoid @ 1337. EMS was called per protocol. 1340- Vital signs were 156/110, HR 84, pulse ox 98%. 1342- EMS arrived- VS 162/110, HR 85, pulse ox 98%. Patient then complained of feeling lightheaded. Patient was transported to ED without further incident

Progress Notes Subjective Patient is a 61 y.o. female who was seen at COVID vaccine clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience left arm paresthesia and aching. She denied rash, hives, SOA. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to skin changes. . Pt received injection to LUE, developed paresthesia to LUE, distal to injection site. ROS/PE unremarkable. No red flag findings to warrant further intervention. Clinically, superficial skin nerve involvement. Dismissed after period of observation. Previous Reactions: none Objective Vitals Vitals: 03/16/21 0843 BP: 121/84 Pulse: 74 Resp: 18 SpO2: 100% Physical Exam Vitals reviewed. Constitutional: General: She is not in acute distress. Appearance: She is not ill-appearing, toxic-appearing or diaphoretic. HENT: Nose: Nose normal. Mouth/Throat: Mouth: Mucous membranes are moist. Cardiovascular: Rate and Rhythm: Normal rate. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds. No stridor. Musculoskeletal: General: Normal range of motion. Cervical back: Normal range of motion. Skin: General: Skin is warm and dry. Findings: No rash. Comments: No injection site erythema, rash Neurological: Mental Status: She is alert. Sensory: Sensory deficit present. Motor: No weakness. Comments: Paresthesia, mild without weakness Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: no therapy Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) Pt received injection to LUE, developed paresthesia to LUE, distal to injection site. ROS/PE unremarkable. No red flag findings to warrant furhter intervention. Clinically, superficial skin nerve involvement. Dismissed after period of observation.

Within minutes of getting the shot in my left arm I started to feel the left side of my neck getting stiff. It felt like the stiffness was creeping up my neck. After about a hour I felt my ear lobes tingling and the left side of my face in the jaw area seemed a bit swollen and felt a little numb. It resolved and I had only a sore injection site the next day and no other symptoms. I'm wondering if I should be concerned about getting the second shot

nausea; chills; diarrhea; bad chest pain could barely breathe; bad chest pain could barely breathe; left arm where the injection was given was very painful from the injection site to her wrist and; left arm where the injection was given was very painful from the injection site to her wrist and; can barely lift her arm over her head; increase in her blood sugar; arm pain; This is a spontaneous report from a contactable consumer (patient herself). A 61-year-old female patient, not pregnant, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9265), via an unspecified route of administration in the left arm, on 02Feb2021 14:30, at a single dose, for covid-19 immunization. Medical history included diabetes, high blood pressure, and sciatica. Concomitant medications included insulin glargine (LANTUS); metformin; hydrochlorothiazide; candesartan; glipizide (GLIPIZIDE XL) and; colecalciferol (VITAMIN D [COLECALCIFEROL]) - all taken for unspecified indications with start and stop dates not reported. The patient previously received sitagliptin (JANUVIA) and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient did not have Covid prior vaccination. The patient received the vaccine in a public health clinic/veterans administration facility. The patient received the Pfizer vaccine dose 1 on 02Feb2021. The patient experienced nausea, chills, diarrhea and bad chest pain could barely breathe - these have passed. Her left arm where the injection was given was very painful from the injection site to her wrist and she has been alternating ice pack/heat pad and taking Tylenol 650 mg for the pain. She can barely lift her arm over her head. She also noticed an increase in her blood sugar and her blood was really dark - she stated this was unusual. She asked if there was anything she can do or take that might decrease her arm pain. All the adverse events happened on Feb2021 and resulted in doctor or other healthcare professional office/clinic visit. It was reported that the patient had not recovered from all the adverse events at the time of the report. No treatment was received for all the adverse events, except for "left arm where the injection was given was very painful from the injection site to her wrist" (alternating ice pack/heat pad and taking Tylenol 650 mg for the pain). The patient has not been Covid-tested post vaccination.

Patient received 1st Pfizer Covid vaccine (lot# ER2613 Exp 7/21) at 1300. At 1320 client informed nurse of flushed face feeling. First set of vials at 1320: pulse 65, blood pressure 132/74, respirations 18. Alert and oriented. No swelling noted or redness. Client denied shortness of breath, chest pain, dizziness. Per client similar feeling when she received flu shot. nurse offered client benadryl, client declined. Client informed she would be monitored for 30 min observation. Current medications: lisinopril, metformin, lovastatin, and vitamin D. No known allergies. 1335 vitals: pulse 74, blood pressure 130/72, respirations 18. Per client flushed face resolved. No other complaints at this time. Client alert and oriented. 1350 client completed observation, no complaints. Flushed feeling resolved. Last vitals: pulse 74, blood pressure 134/80, respirations 18. Advised client to follow up with primary provider before obtaining 2nd Pfizer dose. ER precautions given. Per client husband waiting in car. Client left facility with a steady gait.

Pt called clinic stating that 12 hours after getting vaccine she noticed swelling of left breast and left arm. States that left breast noticeably bigger that the right. Almost double the size from the swelling. Left arm having swelling that started on the inner aspect of the upper arm and has spread down to the elbow. Stated it is tender to the touch and having pain in muscle with moving arm. Not hot to touch. No redness, rash, bruising, shortness of breath, or tightness in throat. Offered an appointment for evaluation at the clinic, but patient declined and preferred to continue to monitor at home. Discussed that if swelling increases or persist to contact the clinic fo an appointment.

Tingling all over; hot and flushed. No treatments needed. Improved on its own approx. 10 min after it started.

Within 10 min I started feeling dizzy, kind of loopy. I didn't think anything of it. I Waited 15 min, got in my car, and felt the need to defecate. Went back in the store, completed, got in my car to drive home. Started to feel even dizzier but kept driving. Felt like maybe I was having a little bit of a strain swallowing but was breathing fine. I took 2 puffs of my Albuterol. Still felt unnatural and anxious. Got home and started to feel a little better within 15 minutes. The arm is sore, not too much of a bother, body aches. Chills for a few hours. Got up and went about my day. Tired and anxious.

[Vaccinated at another site] -- 24 hrs after first COVID dose, she had several days of dyspnea, tremors, headache, tachycardia, and hypertension, all without fever.

acute subdural hemorrhage (presented as word finding difficulty and confusion for 2 days per son who convinced his mother to come in to ED)

woke up with nausea 36 hours after getting the shot. After vomiting I was able to go back to sleep. The entire next day I didn't feel well. Weak, slightly nauseous. All the symptoms lasted approximately 24 hours then I was back to normal. In case it matters. I believe I had Covid last February but it was prior to public knowledge and test availability.

Pt described later after she got home a "warm sensation in her chest and felt like she swallowed a golf ball". Felt similar to GERD she had in the past but she has not had anything other than the shot to trigger this reaction

Pt states that 5min after vaccination she developed a headache, her nose was tingling about an hour later, she took tylenol and currently 4-5h later her lip is tingling.

At about exactly 12 hours after receiving the vaccine. I was sitting in my living room watching TV and a sudden severe pain shot through my chest and followed by tightness and difficulty breathing. It was immediately accompanied by a pain between the shoulder blades, cold sweat, nausea, then neck pain and faintness along with the uncontrollable need to move my bowels which was in diarrhea form and continued 3 times within 20 minutes with the other symptoms. After about 5 minutes of receiving the onset of the initial shocking pain, the intensity of the chest pain left but the tightness remained and faded but would return and then subside again every 10 minutes. I went to the emergency room at 11:20pm discharged at 2:50am on 3/19/21.

Bell's Palsy, right side. Onset 3/10/21. Facial palsy impairing eating/drinking/speaking/blinking/eye closure unable/facial expression droop/unilateral lack of facial movement or facial expression. Reduced salivation.

Extreme dizziness, nausea, mild pain all over body. Tome Meclizine, 25, 2 pil,, 3 p.m. Advil 7p.m. 200 mg Some relief by 12p.m.march 19, 2021 Still dizziness, mild pain, cloudy thinking, not able to function

I had significant chills (causing strong body shaking) starting 3 hours after the shot, followed by 36 hours of intermittent fever combined with chills, fever was high but not measured. I was very weak and at times was unable to get out of bed or stand. I had significant joint and overall body pain, at times unable to stand up straight. As this subsided about 36 hours I remained quite weak. On the night of 16 March I was woken up at 1 am with a very severe headache. I took Tylenol and 5 hours later still had the headache - it subsided after about 8 hours. I additionally had stomach cramping but no vomiting or diarrhea, and had no bowel movements until the episode cleared up. During the 4 days that this occurred I tried to keep well hydrated but still had quite concentrated strong urine. I took Tylenol periodically throughout the 4 days, not starting until after the injection was administered. I still feel a little loss of balance/brain fog and have recurring headaches (not migranes).

My face became numb within 10 minutes of the injection. My throat started to close making it somewhat difficult to swallow, but not to the point of having trouble breathing. It has been 12 hours since the injection and my face still feels numb, but swallowing is just starting to get a little easier. The numbness is mostly around my nose, cheeks and forehead.

Sore arm started within 5 minutes and better after 2 days. Headache & low grade fever within 2 hours and lasted 2 days.

Around 7 hours after the shot the left side of my neck hurt a little along with a little sore throat. That evening, I was really tired with body aches. That night I had deep body aches and vomited. I also had a slight headache and coughing. The worst part was the extreme body aches. I felt like I had been hit by a truck. On Saturday (shot was on Thursday), I?m better but my body is sore and I don?t have much energy.

patient experienced burning sensation, nauseous, weakness few minutes (around 5-10mins.) after receiving shot while seated and in waiting observation area.

1. Cold chills in store, had to use restroom and urinate immediately. 2. Cold chills at home, started to shiver, jaw rattling, immediately had hot tea and wrapped in blanket. 3. Nosebleed, very unusual for me, 7 am. 4. Nosebleed, severe tinnitus, nausea, had to get out of bed and get to restroom, immediate bowel movement, severe dizziness vertigo getting back to bed. Slight tinnitus day after while writing report. Still have low nausea. 5. Sore arm for 4-5 days.

Severe headache; chills; muscle aches; arm and neck pain; arm and neck pain; This is a spontaneous report from a contactable consumer (patient herself). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN9581), via an unspecified route of administration, on 10Feb2021, 04:00PM as single dose in the right arm for COVID-19 immunization at Hospital. Medical history included gastroparesis, gastroesophageal reflux disease (GERD), memory loss. Allergies to medications, food, or other products was reported as yes. The patient was not pregnant at time of vaccination. Prior to vaccination, the patient had been diagnosed with COVID-19. No other vaccines have been administered within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient experienced severe headache, chills, muscle aches, arm and neck pain on 11Feb2021 12:00 PM. No treatment received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected

COULD NOT LIFT ARM, DIZZINESS WHEN LYING DOWN, SEVERE VOMITING, DIARRHEA, HEADACHE, SWEATS, CHILLS,

Headache started approximately 12 hours after receiving vaccine , lasted all night - took 2 Tylenol 325 mg caplets and headache was gone within a couple of hours. Also arm was quite sore first night but much better 2nd night.

On 3/19/2021 around 4:00 I started with body aches, headache, fever, and chilling. I continued with that during the night and on 3/20/2021 I still had the body aches and felt weak. On 3/21/2021 I noticed that I had a rash developing in places. On 3/22/2021 I woke at 5:00 a.m. covered with a rash over my entire body that itched. I took Benadryl and that is when I went to the ER.

Patient received vaccine then sat in the observation area. I was called over when she looked pale and felt dizzy a few minutes after receiving the vaccine. We took her vitals and her O2 was 98%, HR 61, and BP 92/67. Her normal BP is in the 110s. No history of syncopal episodes or diabetes. Patient then became unresponsive to questions and stared off into the distance for about 10 seconds. She never lost consciousness. She proceeded to gurgle up vomit and I called 911. She became responsive again and able to converse normally, but still felt dizzy. We wheeled her to the front, and EMS arrived. She agreed to go to the hospital due to the concern for her unresponsive episode, inability to walk on her own, and living by herself.

States tenderness to top of left rib below arm pit that started around 2/24/21 and went to PCP on 3/3/21 for evaluation. Reports bloodwork ordered. States she has been getting progressively worse with complaints of bilateral hip pain and discomfort to upper and lower back. Reports she had chills on 3/19/21 but no fever and has been in contact "daily" with PCP.

The Covid Pfizer vaccine was injected into my left arm muscle. On March 3, Wednesday, the day of vaccine, immediately after injection, I felt numbness/tingling in lips, upper & lower & inside left of head/brain area, and also brief very sharp pains in my upper body randomly throughout my arms and chest. Intermittent sharp pain in center of chest.- scale 2/10 After the first 15 min, I sat outside the tent, and noticed a numbness in my left leg and foot and sharp pain in my left big toe - (03/21/21 left big toenail showed a light discoloration). Symptoms subsided within an hour, yet a residual minor numbness in my lips, continued, and intermittent sharp pain in center of chest. 2/10 On March 7, Sunday following the vaccine, at 11:00 am I felt definite numbness on the left side of my face. I touched it to determine if I could detect a sensation with my fingers, and I felt the numbness as I touched my face as well. My right side of my face was normal. Residual numbness to left face/head intermittently. including today more noticeable March 22, 2021.

12hrs after my 2nd Covid Vaccine I was sleeping got up out of my bed at 4am and the room was spinning. I layed back down and had a burning sensation in my chest and my hands and feet were clammy. Several hours later at 8am same exact reaction when getting out of bed. Over the course of 3 days I remained Lightheaded.

Around 11, 11:30 the pain woke me up because it was so bad. It was hot and there was a big lump under my left arm pit (was very tender). I did not go to sleep like that. I did not have any symptoms by the time I went to bed. I also felt hot, and then cold, then hot, then cold, I would feel too hot and then too cold, freezing, I could not keep my temperature under control. I had to call in at work during the weekend I was feeling so bad. I had a lump under my armpit the size of a fist and I could not close my arm completely. It was huge and painful. I decided to go to a clinic over the weekend (unsure if Saturday or Sunday) to seek medical care and they ran some labs and a CBC to check for infection. All results came well no infection. They suggest to keep taking Tylenol. By Monday or Tuesday I started feeling well enough to return to work. The lump was still present and took about a week to go down. The injection site also was sore for a while, about a week also like the lump.

I woke up about 3am with a fever and freezing to death. I was very lethargic. As the days progressed, I became very weak and wanted to sleep all of the time. I lost my appetite, taste and smell. I was tested for COVID on 1/12 and found out I was positive the next day. I was out of work for 2 weeks and returned to work on 1/25/21. I got an infusion on 1/20 so I can't get my 2nd dose until 90 days after that date.

Immediately: headache, left eye pain, nausea, cold sensation and felt ?weird? but thought it was normal and thought I might feel flying for a bit but that it would wear off so I did not report feeling anything at the clinic. I left the clinic and got in the car to drive home and felt a weird feeling in my throat reminiscent of my esophageal spasm and then it felt like someone had their hand on my throat squeezing my throat and felt like I needed to take deep breaths to expand my lungs. Within a minute or two at most, my lips, tip of my tongue, tip of my nose and face beside my lips and under my cheeks started to tingle and go numb. My insides felt swollen. I had a doctors appointment and went there after picking my son up at home. I reported my feeling to my doctor who prescribed a steroid for 3 days and told me to also take Benadryl or Claritin, which I did. However, today is day 4 after my vaccine and today is the first day my insides don?t hurt.

Pfizer-BioNTECH Covid-19 Vaccine EUA Upper arm ?shoulder pain. Shaking chills, Body aches. Started at 1 a.m. on 3/23/2021. Tylenol 1000mg taken at 5a.m . Chills and muscle aches lasted until 12 noon. Deeling tired and very mild muscle aches continue. Tylenol 1000 mg taken at 4pm.

Slight neuropathy over thumb into thumb - tingling to outright pain on touch. Is subsiding at this time, but still present but less painful.

BP dropped to 70/40; seizures; She did fall into a cabinet; bruised up; inflamed; back was on fire; if she moves her head quickly, she can feel like she will have a headache, hangover; could not walk; Trouble walking; Funny taste in mouth; Pain/ felt achy; tingling sensation from head to her to spine/ hands tingling/ it was also in her abdomen area and in her leg; Back pain; Could hardly move; could not stand up; autoimmune response; delayed allergic reaction; tweaky muscle/ pulled a muscle in her back; pain at the top of her head down to her hip; pain at the top of her head down to her hip; having trouble holding her urine; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID19 VACCINE, Solution for injection, lot number: EL9266), via an unspecified route of administration in the left arm, on 05Mar2021 1:45 PM at a single dose for COVID-19 immunization. The patient did not receive any vaccines within 4 weeks prior to receiving the BNT162B2. Medical history included allergic reaction, autoimmune disease, brain barrier fever, epilepsy, encephalitis and meningitis. She had epilepsy as a child. She gets epilepsy when she gets sick. The last 4 times she got sick she had a seizure. The last seizure was 1 year ago (in 2020). She may have had COVID, but she got really sick and had a seizure. She is not sure if it was COVID or not. If it was the flu, she does not want that again. She had ataxia and ended up in hospital two times but did not stay. Prior to this, she did not go to hospital for 30 years. She was unable to walk, her gait was real bad. The neurological disorder messed her up for a while. Concomitant medications were not reported. It was reported that the patient received the PFIZER-BIONTECH COVID19 VACCINE first dose and experienced autoimmune response. After the vaccine, she had pain and tingling sensation from head to her to spine (05Mar2021), BP dropped to 70/40 (06Mar2021), seizures (06Mar2021), and delayed allergic reaction (Mar2021). She wanted to know if she should take the second dose or not. She also wanted to know if that would be considered the anaphylactic reaction. It was also reported that the patient experienced funny taste in mouth, back pain, hands tingling on 05Mar2021. The patient further explained that when she got the shot, she had a funny taste in her mouth. It started immediately after she got the vaccine and it lasted 30 minutes. She mentioned this to the people at the facility, but they said she was crazy and no one else has mentioned this. She thought they would be interested, but they did not care. About 20 minutes later she had a tingly sensation. It was in the back of her head that developed into a stingy, painful, heat, funny type feeling. It was all the way down to her back. She later further explained the back of her head was tingling (05Mar2021). Like were the cerebellum is to spine. This sensation is still there, but better. After she felt this feeling her back then started hurting. She bent over and her back went out. She felt achy. She already had what she called a tweaky muscle (05Mar2021). She had pulled a muscle in her back, but it was nothing that had caused a problem. After getting the COVID vaccine it triggered an immune response in her body. She started to have pain at the top of her head down to her hip (05Mar2021). She bent over and she could not stand up (05Mar2021). Her husband had to help her put her pants on and sit down due to this. She started to have horrible back pain (05Mar2021). She could hardly move (05Mar2021). She was having trouble walking (05Mar2021). She was having trouble holding her urine (05Mar2021). On Saturday evening (06Mar2021), her blood pressure started dropping and she later had a seizure. After the seizure occurred it seems like everything got better and she did not have any trouble since. It was very scary. She mentioned she was in the bathroom and there was a tub full of water. She had a hard time already getting to the bathroom. She was in a lot of pain. The amount of pain she had she thinks affected her blood pressure. She had pain in the back, middle of her back. It started at her head, back of head, down her spine, came down to her back and hips. She was hurting a lot and having a terribly hard time getting around. She could hardly walk. She was going to the bathroom because she felt like she had to go. Her husband was helping her sit on the toilet. When she stood up it was like her blood pressure dropped, she almost went headfirst in the tub full of water, but her husband caught her, laid her down, and had a seizure. This was a very unnerving feeling. The seizure did not last more than a minute, maybe two at the very most. The seizure occurred probably around 6PM or 7PM. It did not last long at all. She woke up on the floor. She had been sitting and she thought she had fallen off the toilet. However, her husband had to remind her that a few things happened in between. She almost fell in the bathtub and she has glass doors. She mentioned she felt as clarified and confirmed sped up. She did fall into a cabinet and is bruised up from that seizure (06Mar2021). She is sore from the pain from that. Still inflamed (06Mar2021) possibly due to the seizure. Like she has ruminants of what occurred to back of head, cerebellum. Before she had the seizure, her blood pressure had started dropping. It started dropping in the evening around 5PM or 5:30PM. Mentioned she is a little confused about the time onset because she was hurting so much and bad all day. She does not take any pain medication. She has an autoimmune disease and it is difficult for her to take medications. On top of that, if she wanted to take an Aspirin she was told she should not take one. She was informed she was trying to promote an auto-immune response to the vaccine. As the day ran on, she was in a lot of pain. She had been in pain since Friday and was trying to deal with that. The patient further stated her blood pressure is back, no illness. After the seizure her blood pressure went back to normal and at this time it is perfectly fine. The back pain she experienced went from the brain down to her backbone. The pain is gone. It started to go away after the seizure and by Sunday 07Mar2021 it was totally gone. At first it was like she could not walk (05Mar2021). It was like she/her back was on fire (05Mar2021). The patient also mentioned if she moves her head quickly, she can feel like she will have a headache, hangover. She feels it in her back. She feels like she is near recovery, and this is a feeling she does not thing will stay. She further went on to say her hip where she fell is a different story. However, this is associated to a fall and not a vaccine. She was having this problem when she had the vaccine, but the vaccine caused it to be more and extra aggravating. She later added, when she first got home along with head tingling her hands were tingling as well. When her brain and hands were going through this tingling sensation, she started to notice the back trouble and it was also in her abdomen area and in her legs causing trouble walking (05Mar2021). The events did not require a visit to the emergency room or physician office. Outcome of the events trouble walking, could not walk, tingling sensation and hangover was recovering. Outcome of BP dropped to 70/40 was recovered on Mar2021. Outcome of seizures recovered on 06Mar2021. Outcome of funny taste in mouth was recovered on 05Mar2021. Outcome of back pain was recovered on 07Mar2021. Outcome of bruised up was not recovered. Outcome of the remaining events was unknown. The patient provided an unrelated causality between the vaccine and event fall. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the current available information, the event Fall is most likely related to an intercurrent or underlying condition which is not related to the suspected drug.

Fainting, fever, chills, nausea. Had repeated fainting spells the morning after the day I was vaccinated. Felt better the next day, still had slight fever. By Wednesday (third day after vaccine day), felt fine. The reason I am reporting this is the fainting episodes. I do not see that online as a listed common side effect of the vaccine.

Got hot, felt nauseated, fast heart rate and a little light headed and dizzy I also did not eat before i got the shot they seem to think my sugar dropped as soon as i had something to eat and drink i was fine

I started developing painful nodules upper neck(right), around outside ear(sright) lower jaw line. Being a nurse I thought I was breaking out as the days went by I noticed it was Shingles.

Diabetes; unable to concentrate; arm is killing her; hands are swelled up; constipated; nausea; tightening of chest every so often; acid reflux; hot flashes; sweating; stomach aches; upper abdominal pain radiating to back; severe fatigue; Dizzy/dizziness; stomach feels odd; Headaches; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot Number: EN6198), via an unspecified route of administration, administered in upper left arm on 25Feb2021 9:00 (at the age of 61-year-old) as single dose for virus (COVID-19 immunisation). Medical history included chronic pain, pancreatitis, allergic to medications, old injury in her right arm, menopause and an ongoing mass in parotid lobe discovered in 2019 with CT scan. MRI performed in Mar2020 and CT scan in Oct2020. She stated that they are just watching it because it has not changed. Well defined borders are present, caller stated that doctor was unconcerned. Her mother had heart disease. Ongoing concomitant medications included ibuprofen for chronic pain and gabapentin from 2019 for chronic pain. The patient also took unspecified medication for pancreatitis. She has taken all kinds of stuff after pancreatitis but they do not work. The patient got deadly ill from the flu shot. Unsure of onset age, vaccine/brand name, or vaccination date. She stated that it was before 2003, possibly in the late 1990's or early 2000's. The patient had no history of all previous immunization with the Pfizer vaccine and no additional vaccines administered on same date of the Pfizer suspect. On unspecified date the patient experienced diabetes; on 25Feb2021, the patient experienced dizzy, stomach feels odd, hot flashes, severe fatigue, sweating, stomach aches, acid reflux, upper abdominal pain radiating to back; on 26Feb2021 she experienced tightening of chest every so often; and in Feb2021, she had headache. It was further reported as follows: The patient stated that she took the Pfizer shot, clarified that she received the Covid-19 vaccine, on 25Feb2021, not quite 2 weeks ago. She stated that she had a little bit of a reaction after receiving the vaccination while there, so they were monitoring her. She has been experiencing hot flashes, sweating, and stomach aches for 2 days. She cannot get rid of hot flashes and that she has not had a hot flash in 2 years. She states that she has been down for 2 days with fatigue, that it's really bad. She is inquiring if the side effects that she is experiencing are common side effects and if it is ok to get 2nd shot. Her second vaccine is scheduled for 17Mar2021. She stated that she wanted to take the time to make a report as she is allergic to medications. While inquiring about dates of vaccines and side effects, she stated that she was experiencing tightening of chest every so often. She stated that she only had a few days of stomach pain and she has not stopped eating. She is unable to concentrate (unspecified date) and she has been experiencing headaches, experiencing them twice in 2 weeks. She also reported that she has been having upper abdominal pain radiating to her back. This concerns her, every time she gets it, it scares her. She had pancreatitis when she was 36. It is a nightmare thought. Does this sound like maybe she is possibly starting Diabetes? She reported that this shot has triggered everything. She has an old injury in her right arm. Her arm is killing her, her hands are swelled up, she has acid reflux again, she felt terrible. She stated that the dizziness not as strong as it was at the beginning. The fatigue it comes and goes and that she has spurts where she is energetic. She stated that it's more on than off. She is no longer having stomach aches. She compared the pain to pains of constipation. She also stated that she was constipated after receiving the vaccine on unspecified date. She had nausea at the beginning. The tightening of chest happened off and on, the last day that she experienced tightening of chest was on Sunday. For acid reflux, she is taking Zegerid as treatment, 20mg 20 mg capsules by mouth once daily as needed. She started this on 02Mar2021. She experienced upper abdominal pain yesterday and some this morning, but it was mostly in her back this morning. Her Sweating is off and on. She experienced headache just a couple of times but that she has not had one in a while. She stated that they lasted only an hour or two, and that she does not usually get headaches. She suggested that these may be due to sinuses and weather change. She has been taking Ibuprofen twice a day as treatment. But she normally takes Ibuprofen for chronic pain. Supposed to be 3 times a day but she does not want to take that much. She stated that all of this could also be stress related and that this could also be menopause. The patient recovered from stomach aches on 02Mar2021. The outcome of the events dizzy, sweating, tightening of chest every so often, upper abdominal pain radiating to back, headache was recovering; the outcome of stomach feels odd, hot flashes, severe fatigue, acid reflux was not recovered. The outcome of the remaining events was unknown.

Huge bruise with a knot. Warm to touchArm pain to the point I couldn?t lay on it. Side effect symptoms started 3 days after injection on 03/24/2021. Headache, chills, fatigue, atypical chest pain.

On 3/22/21 I experienced several bouts of diarrhea coupled with clammyness/sweating/heart rate of 102. On 3/22/21 and continue to have swelling in my left armpit (Lymph node area), spasms in my left shoulder blade and surrounding soft tissue adjacent to my left armpit and neck area. I have experienced soreness in that arm/shoulder but not at the injection site - overall bicep and clavicle area. I have been able to alleviate symptoms to a degree by taking a tylenol once or twice a day but the pain is limiting some of my daily activities to a degree.

Throat tightness with difficulty swallowing, tingling to face and head. Lasted approx 10-15 seconds. Went to the emergency room and was stable at the time. Toward the latter part of the ER visit, I was given prednisone, Pepcid, and Benadryl. Have had no issues since then.

3 days after completing vaccine series, pt develop right leg pain and swelling, which progressed later on to shortness of breath after a week.

3-25-21 2:50PM PT STATES 'LEGS FEEL TINGLING'. PT AMBULATORY GAIT BRISK/STTEADY. NO SOB, NO PAIN. GOOD CAP REFILL TO FINGER TIPS. PT STATES SHE CAN 'FEEL THE MEDICINE ALL IN HER BODY'. A/O, PINK W/D, RESP REG WITH EASE.2:25PM TO EXIT PER WHEELCHAIR TO BE TAKEN HOME PER HUSBAND. NO ACUTE DISTRESS NOTED. 3-26-21 8:17AM PT STATES SHE 'FEELS FINE TODAY; NO TINGLIN IN HER LEGS'.

Began with waves of prickly hot sweats, light headed dizziness, cold chills, nausea. Got progressively worse-was at dentist, sent home, could not walk unaided (dizzy). Threw up in car on way home. Spent evening with these sympyoms gradually decreasing in strength, very fatigued, took effort yo breathe. Also soreness of arm. Next day: very fatigued, sore arm, but test of symptoms passed (little nausea, but not bad)

Between 10 and 15 minutes after receiving the vaccine, I felt like someone had thumped me in the chest over my left breast. I tried to breathe deeply, and I started to feel light headed. I didn't tell anyone, I was let go after 15 minutes. I sat in my car about 5 minutes and then decided I was worse. I was weak and shaky and light headed, my top lip was fuzzy feeling. I didn't feel like there was a blockage in my airway but I felt like I was having trouble getting my rib cage to expand so I could breathe. I went back in and was sat down, I was evaluated. Paramedics were called, by time they came I was lightheaded and I was foggy brained. I couldn't respond easily. My BP was 165/99 and my heart rate was 98. my O2 was fine but by that time I felt like I had to work hard to get a deep breath. I was feeling worse quickly. I was taken to the ER in a wheelchair. I was put in a bed and hooked me up to monitors. I was left alone for a while. When the dr came in he checked me out and listen to my lungs. I had a hard time getting my lungs to expand. Doctor ordered a blood sugar test and it was below 100. Chest x-ray, EKG and blood work. He told me later that everything was normal. I was there for 2 hours before I felt like I could go home. I didn't receive any medication. I was able to breathe easier by time I left the hospital. I was thinking more clearly as well. The next day I was still feeling shaky and weak. I went to my PCP on friday and I was feeling normal by then.

Sore arm for about 3 days. Then a week later I suddenly got cold hands, legs, stiff neck, swollen head, dizzy, multiple bowel movements, week leg muscles, tired. Lasted about 1 hour for initial wave, then was tired and out of commission for about 3 hours afterwards.

Beginning around 8:00 pm I felt prickly all over my body. Not severe, but uncomfortable. I believe I also developed a minor rash. I took benadryl that night and slept fine. I felt the same way on 3/23/21 and took benedryl again. It seemed better 3/24/21 but came back on 3/25/21 and has continued today 3/27/21. After a walk outside with no jacket it is feeling better, but I can tell it's still there. Called my doctor on 3/23/21 and she recommended benadryl at night and allegra or claritin during the day. And ibuprofen and pepcid. I only have taken the benadryl. She advised not getting the second shot.

Patient complained of hot flash and feeling "heat across chest." Pt refused ambulance treatment or transport to hospital ER. Patient would go to ER on their own.

Pfizer COVID-19 Vaccine EUA Patient presents 3/23/21 for medical monitoring of syncopal episode s/p COVID - 19 vaccine # 2. Lowered to the floor by vaccine staff. Patient reports symptoms of weakness, other wise states she ""feels fine"". Two additional syncopal episodes witnessed by myself when patient attempts to change position. Past medical history is significant for mild persistent allergic asthma, pre-diabetes, OSA, obesity and BPPV. Patient reports history of same reaction s/p previous vaccine. At a approximately 0837 patient was noted to have a worsening rash present to her face. EpiPen administered via left lateral thigh at 0838. EMS called to transport patient the ED for further evaluation. Treatment administered: epipen (lot 0FM406, exp 02/22) left lateral thigh at 0838. Upon arrival to the ED, patient's temperature is 98.8° F, heart rate 92-103, respiratory rate 30, saturating 99% on room air with blood pressure 164/91. The patient's laboratory studies were largely unremarkable. While in the ED, the nurse was getting ready to get the patient up to the commode when the patient started to ""not feel right again."" She asked her to administer the medications for allergic reaction and reports wall the 2nd medication was being infused, she felt paralyzed and unable to talk, although she was able to hear everything and was aware, she was unable to move or speak for a short amount of time. CT head with completed at this time and showed no acute intracranial findings. Chest x-ray unremarkable. EKG showed normal sinus rhythm with sinus arrhythmia, heart rate 80 and prolonged QT at 470. The patient was administered Solu-Medrol 125 mg IV, Pepcid 20 mg IV, Benadryl 50 mg IV, normal saline 1 L IV. Pt was admitted to hospital for observation. The patient was seen on the unit laying in bed with her husband at the bedside. She reports that she is feeling slightly better and hungry and has never felt at paralyzed/unable to speak feeling before and is very nervous about this. She was wondering if she had a seizure, although she reports feeling aware the entire time and did not lose bowel or bladder function. We discussed that that is not typical for a seizure, but even if we did an EEG at this time, it would not be able to tell us what occurred in the past. We discussed continue the Benadryl, Pepcid, and IV steroids for today and likely decreasing them tomorrow. We discussed the workup of syncopal episodes as well. The patient and her husband were agreeable to this plan. Patient was discharged from the hospital on 03/24/2021 in a stable medical condition. Patient was instructed to follow-up with her PCP in 1 week.

Pfizer-BioNTech COVID-19 Vaccine EUA The area received vaccination was sore, about two hours later became drowsy, had to leave work and go home, woke up around 5 p.m. body ached on left and right side, took Aleve for pain.. Overnight had chills, headache, next morning, took Aleve for pain. Whole body ached for about a week, headaches, lethargic, tiredness. About week and half later only ache in right arm, sore like I sprained it, still tender today.

weak, cold, throwing up, hot flashes, dizziness, head hurt, sweating in sleep, diarrhea , body pain, nausea

3/11-3/12/21 - heart palpitations, start of flu symptoms 3/13-3/18/21 - heart palpitations and high heart rate, blood pressure high and low, chills, weak, diarrhea, nausea, headache 3/19-3/23/21 - heart issues better, still had flu symptoms Propanolol and Alprazolam for heart palpitations. ER visit 3/16 - recv IV's, all labs normal. PCP visit 3/23.

Approximately 25 minutes after receiving the vaccine I noticed my eyes were beginning to itch and my throat felt odd and was accompanied by a hoarse voice. I was driving home at that point and considered turning back for medical advice (should have but did not). Over the next few hours itching sensation on my tongue, face including eyes, head and back. Developed just one hive on my eyebrow approx 3 hours after vaccination, and one on my thigh at least six hours after vaccination. The symptoms were not severe but obviously I monitored them. Now 24 hours after the vaccination and still have some itching as described above. Throat is somewhat better. Eyes feel odd more than itchy at this point.

Left index finger from 2nd joint to too is numb and I frequently have tingling in my left index finger and left thumb. This started right after I had the vaccine and is ongoing.

total of 4 days tired/weak, and right arm sore (from thursday through sunday) early saturday morning had 4 hours of hallucinations, nausea and extreme vomiting, dizzyness ,loss of appetite slept for 12 hours on saturday and sunday after the 4 hrs of events listed above. still weak after feeling better on sunday afternoon

Hit with heaviness limbs; whelps all over body arms legs stomach back groin; pain in joints; felt like fire ants; chills; no energy; tightness in chest; This is a spontaneous report from a consumer reported for herself. An 61-year-old female non- pregnant is unknown female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6198), via an unspecified route of administration on Left arm on 02Feb2021 17:45 at single dose for covid-19 immunisation. Medical history included COVID-19, Congested Heart disease, and Penicillin allergy. The patient's concomitant medications were not reported. The patient experienced Hit with heaviness limbs pain in joints whelps all over body arms legs stomach back groin felt like fire ants chills no energy tightness in chest on 22Feb2021. Received Inhalers for breathing and steroids. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19; Since the vaccination, the patient not been tested for COVID-19. The seriousness was reported as non-serious. The outcome of the events was "Recovering".

pain / swollen area where injection given. joint pain in every joint in my body - never had this before vaccine. Facial muscel spasms; both eyes and left side of cheek area. Never had this before.

Dizzy; Medicine taste in her mouth; Head and neck pain; Head and neck pain/pressure in the face and back of the neck/pressure in jaw and neck; Pressure in the face and back of the neck/pressure in jaw and neck; Pressure in jaw; Pressure in the face; Heaviness in her legs; Cold symptoms in her chest, almost like bronchitis; Cold symptoms in her chest, almost like bronchitis; Throat started getting scratchy/scratchiness in her throat; Itchy in her ear; Phlegm feeling in her throat; Allergic reaction; Getting twitches and surges/felt surges in her leg, like adrenaline shooting through her with no letting up; Tingling in her mouth near her lip and her foot and then in her hand; Tingling in her mouth near her lip and her foot and then in her hand/jolt in her left leg; Not well/feeling of unwell; Spaciness/doesn't feel like herself/feels off/Is in a fog/fogginess; Her mouth is shaky/shaking; Unsteady; She feels like she has a lot of adrenaline; Felt cold; Muscle weakness; Getting twitches and surges; Laborious to walk; Itchy sensation; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6201; Expiration date was not reported) on the right arm on 08Mar2021 (08:30) as a single dose, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included being allergic to sulfa drugs and x-ray dye; and had seasonal allergies. Concomitant medications included paracetamol (TYLENOL) and vitamin D3. The patient previously took doxycycline, and was allergic. On 08Mar2021, the patient had cold symptoms in her chest, almost like bronchitis; throat started getting scratchy/scratchiness in her throat; itchy in her ear; had a medicine taste in her mouth; head and neck pain; pressure in the face and back of the neck/pressure in jaw and neck; heaviness in her legs; and phlegm feeling in her throat. In Mar2021, the patient had an allergic reaction; getting twitches and surges/felt surges in her leg, like adrenaline shooting through her with no letting up; had tingling in her mouth near her lip and her foot and then in her hand; tingling in her mouth near her lip and her foot and then in her hand/jolt in her left leg; not well/feeling of unwell; spaciness, did not feel like herself/had felt off and was in a fog/fogginess; mouth was shaky/shaking; was unsteady; had felt like she has a lot of adrenaline; had felt cold; muscle weakness; was getting twitches and surges; was laborious to walk; and had itchy sensation. On 09Mar2021, the patient was dizzy. The events resulted into physician's office visit. The patient's blood test, electrocardiogram (ECG), electrocardiogram (EKG), "two other panels", metabolic and all tests showed everything was normal on an unspecified date. The outcome of the events was unknown. The patient's second dose of vaccination was scheduled on 29Mar2021.

Fatigue; Fever (101.6); Chills; Shakes; Muscle pain; Joint pain; Headache; Foggy head; Loss of appetite; Nausea; Sore arm at injection site (minor); Swollen lymph gland under left arm; Dizzy; This is a spontaneous report received from a contactable nurse (reported for herself). A 61-year-old female patient received second dose of BNT162B2 (Comirnaty, Solution for injection and Lot number: EL3246), intramuscularly to left arm on 12Jan2021 10:00 at a single dose for COVID-19 Immunization. Patient medical history was reported as none. Patient concomitant medications included calcium, ergocalciferol (VITAMIN D), multivitamin and probiotic. The patient previously took BNT162B2 (Comirnaty, Lot number: EJ1685) vaccination, intramuscularly to left arm on 22Dec2020 for COVID-19 immunization. On 12Jan2021 22:00, 12 hours after the second dose of vaccination the patient experienced with fatigue, fever (101.6), chills, shakes, muscle pain, joint pain, headache, foggy head, loss of appetite, nausea, sore arm at injection site (minor), swollen lymph gland under left arm. patient was on bed and felt dizzy after fever broke for about 24 hours. Seriousness was reported as non-serious. Patient received on advil at night for treatment of events. The outcome of events was recovered on an unspecified date. No follow-up attempts are possible, No further information available

Left side got tight including brain/ brain was not cooperating with the eyes/ Brain shaking; Profuse sweating; Never had low blood sugar before/Blood sugar crashed; Left side got tight; This is a spontaneous report from a contactable other hcp (patient). A 61-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 03Mar2021 08:45 am (Batch/Lot Number: EN6203) at age of 61-years-old as SINGLE DOSE for covid-19 immunisation. Medical history included diabetes. No pregnant. No Covid prior vaccination. No Covid tested post vaccination. No Known allergies. No other vaccine in four weeks. Concomitant medication included semaglutide (OZEMPIC), metformin (METFORMIN), lisinopril (LISINOPRIL), all empagliflozin, linagliptin (GLYXAMBI) taken for an unspecified indication, start and stop date were not reported. The patient experienced left side got tight including brain/ brain was not cooperating with the eyes/ brain shaking, profuse sweating, never had low blood sugar before/ blood sugar crashed on 03Mar2021 09:30. Adverse event: Left side got tight including brain. After maybe 20 minutes while she was driving back. Blood sugar crashed and brain was not cooperating with the eyes. Brain shaking. Profuse sweating. Ate something when she got to work and started improving. Never had low blood sugar before. No treatment for events. The patient underwent lab tests and procedures which included blood glucose: low/crashed on 03Mar2021 09:30. The event outcome recovered in Mar2021.

My face became warmth /her arms felt slightly warm; My face became warm, red/flushed; My face became tight and tingling/her arms felt slightly tingling; This is a spontaneous report from a contactable consumer(patient) reported for herself. A 61-year-old female patient (not pregnant) received first dose of bnt162b2 BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6206), in arm right on 08Mar2021 at 18:45 (at 61 years) at single dose for covid-19 immunisation. Medical history included high blood pressure and high cholesterol.Concomitant medications included atorvastatin, lisinopril, "Multi vit", calcium, ascorbic acid (VIT C) and ergocalciferol (VIT D), all taken for an unspecified indication, start and stop date were not reported. The patient previously took diphenhydramine hydrochloride (BENADRYL) and experienced allergy. On 08Mar2021 at 19:15 the patient's face became warm, red/flushed, tight and tingling and her arms felt slightly warm/tingling. All symptoms were gone within 2 hours of vaccine. No treatment given and patient recovered from all the events on 08Mar2021. No follow-up attempts are needed. No further information is expected

felt like I was going to hit the floor; Lightheadedness/Dizziness; jerking/involuntary jerking, quenching, it was kind of weird; body jerking; feeling weird/felt like she was not herself/ she felt her body was trying to fight off something; heaviness in her legs; felt pain in her face; flinching; This is a spontaneous report from a contactable consumer(patient). The 61-year-old female patient received first dose BNT162b2, via an unspecified route of administration on 04Mar2021 (Lot Number: EN6205) as single dose for CIVID-19 immunization. Medical history included blood pressure issues from 2010 and ongoing, ongoing sinus issues which was diagnosed in 1973 or 1974, hypoglycaemia, reaction to tetanus shot several years ago. The patient's concomitant medications were not reported. She received postnasal drip started on 02 Mar2021 or 03 Mar2021 before the vaccine. She got the first Covid shot on 04 Mar2021. She wait 30 minutes because had reaction to tetanus shot several years ago. She had flinching, jerking and feeling weird 10 minutes after vaccine on 04 Mar2021. She and husband in holding area waiting. One time jerk so bad felt that she felt she had to lay down. She felt like she was not herself like she was out of body like there and she was not (AS REPORTED). She had a weird feeling after vaccine, she felt her body was trying to fight off something, felt like little bit out of body feeling, felt like she was going to hit the floor on unknown date. She felt lightheadness on 04 Mar2021. They checked her pulse and there was nothing with her heart rate. She does not know if it was an anxiety attack or not. She was nervous about getting the vaccine because it was so new. She felt this way for four days. On the fourth day that she felt she was coming around and on the fifth she felt herself. She has other underlying health issues and does not want the virus. She had heaviness in her legs, felt a pain in her face both on 04 Mar2021. The doctor wanted to rule out if she was having a stroke. She went to the ER, the ER kicked her out and did not find them. Her BP was 130/60 on 09Mar2021. They did blood work and an EKG(Electrocardiogram). They ruled out stroke. The doctor stated that the allergies could have made her feel dizzy but did not know about the twitching and jerking. She has lightheadness and dizziness because of other health reasons like sinuses, blood pressure and low blood sugar which these were before the vaccine. She had the normal EKG on 09 Mar 2021. There was unknown treatment received for events. Outcome of heaviness in her legs was recovered on 06Mar2021, of felt pain in her face, feeling weird, Dizziness was recovered on 07Mar2021, flinching, jerking was recovered on 04Mar2021, of felt like I was going to hit the floor was unknown. Case was assessed as serious.

Went to dialysis and within 2 to 3 hours had symptoms of a seizure. Loss of memory for 2 to 4 hrs acting stiff and unusual behavior; Went to dialysis and within 2 to 3 hours had symptoms of a seizure. Loss of memory for 2 to 4 hrs acting stiff and unusual behavior; Went to dialysis and within 2 to 3 hours had symptoms of a seizure. Loss of memory for 2 to 4 hrs acting stiff and unusual behavior; temp of 101.6; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in Arm Right on 01Mar2021 17:15 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included end stage renal disease (ESRD), high blood pressure and pulmonary hypertension; all from an unknown date and unknown if ongoing. The patient has no COVID prior vaccination and not tested to COVID post vaccination. There was no other vaccine in four weeks. Concomitant medications (reported as Other medications in two weeks) included clonidine (CLONIDINE), macitentan (OPSUMIT), minoxidil (MINOXIDIL), carvedilol (CARVEDILOL), and tadalafil (ADCIRCA); all taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2 (lot number: unknown) first dose on 22Jan2021 at 02:45 PM right arm for covid-19 immunization. The patient also previously took Hydralazine and experienced allergies. It was reported that on 01Mar2021 08:00 PM the patient went to dialysis and within 2 to 3 hours had symptoms of a seizure. Loss of memory for 2 to 4 hrs., acting stiff and unusual behavior. The patient's daughter took the patient and had a temp of 101.6 was sent home Tuesday morning. The events resulted in: Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovered with sequalae (reported as with lasting effects). No treatment was given for the events. Information on the lot/batch number has been requested.

The first day she felt severe fatigue within hours. Went to bed and slept all day and all night. The next day woke up disoriented and weak. Called dr and dr recommended her call the ambulence. Went to ER and admitted to hospital. They said she had an infection and got on antibiotics. In the hospital 2-3 days and dismissed. Continue to have weakness and severe fatigue. Had 3 "MS hug"- muscles severely contract during this time- has to take muscle relaxer.

feels a little dizzy; Noticed her voice is not quite right; feels kind of wierd; significant loss of hearing in right ear; when she eats fruit, she notices blocked feeling in her ear. When she talks she notices an echo in her ear; muscle pain in injection site the first night after her dose; Sore Arm Left; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose bnt162b2 (PFIZER COVID VACCINE), via an unspecified route of administration, administered in Arm Left on 20Mar2021 (Batch/Lot Number: ER2613) as single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient received first dose of PFIZER COVID VACCINE last Saturday 20Mar2021. On 26Mar2021 the patient reported muscle pain in injection site the first night after her dose but it only lasted one day. Today 26Mar2021 noticed significant loss of hearing in right ear and feels a little dizzy. Noticed her voice was not quite right. She stated she felt kind of weird. When she eats fruit, she notices blocked feeling in her ear. When she talked she noticed an echo in her ear. She stated she was typically healthy. had this been reported and wondering when it will go away. On 29Mar2021 she stated she called last Friday and reported it because she was so frightened that she had lost her hearing in her right ear. She stated that after one day, her hearing half recovered and after two days, her hearing completely recovered. The patient experienced hearing loss in right ear from 26Mar2021 and sore arm left from 20Mar2021. She stated that she was 61, almost 62 and was very healthy, no medications, not sick. She stated her last vaccine that she had was in childhood. She stated that she doesn't get the flu shot and doesn't get the flu, nothing really. She stated that she had this vaccine for other people, for their concern, she was not worried. She stated the first night, she felt muscle pain in her arm and then she forgot about the vaccine, until Friday. She stated she realized when she searched sudden loss of hearing. She stated that it was all gone. She stated she thought should she have the second one, She stated she thinks it was fine. Clarifies that the first morning she noticed it when she got up it was a little weird, She stated she couldn't hear something, so she started searching this and said she better check it out because it said she needed to get treated sooner. She stated she thought what should she do and was in a panic and that was how she went on the internet and make the link. She stated she wanted to let Pfizer know that everything was back to normal. The outcome of event 'significant loss of hearing in right ear' and 'when she eats fruit, she notices blocked feeling in her ear. When she talks she notices an echo in her ear' was recovered on 28Mar2021, of event 'muscle pain in injection site the first night after her dose' and 'Sore Arm Left' and was recovered on 21Mar2021, of other events was recovered on an unspecified date.

not sure if she has Covid; not sure if she has Covid; she got sick; queasy stomach; hurting of her arm that she got the vaccine in; This is a spontaneous report received from a contactable consumer (Patient). A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 03Mar2021 13:00 (Batch/Lot Number: EN6206) at the age of 61-years-old as single dose for covid-19 immunisation. The COVID-19 vaccine was administered in parking lot. Not at Military Facility. The patient's medical history reported as none. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historic vaccine included 23 years ago with her 1st flu shot she got sick but has not had any issues since. Patient stated she was scheduled for the 2nd Pfizer shot today and she got sick and was not sure if she has Covid on 23Mar2021. Stated she didn't want to get the 2nd shot and exacerbate her symptoms, states she got symptoms with her first shot. Patient was wondering if she can reschedule her shot in general as it was scheduled for today. Patient stated the symptoms after the 1st shot were not detrimental, she had a queasy stomach later that night and natural hurting of her arm that she got the vaccine in. Stated it started that night after 12 at night. Clarified she got the shot 03Mar2021 and the symptoms started after midnight making it 04Mar2021. Stated the symptoms didn't even last 24 hours and were gone by 05Mar2021. No Emergency Room and No Physician Office visit required. The outcome of the events 'hurting of her arm' and 'queasy stomach' was recovered on 05Mar2021 and the outcome of the events was unknown.

I experienced a slight headache sore arm and elevated blood pressure after the shot. My blood pressure is usually very well controlled. On Monday the 29th, at about 3:30 pm, I started to slur my words. At first we blamed it on the Novocaiine earlier in the day, but I had been talking fine after it and had had it many, many times before and it was worn off. We called my doctor's office after my right arm and leg became very heavy and awkward. They told me to go to the nearest hospital. When I got there, I presented ass a full stroke. I was very hard to understand and my mouth drooped and I had very little use of my right arm and leg. They ran tests, but could not give me the medication because I was already on Eliquis. They thought they saw a small clot very high up. I was hospitalized over the next four days and improved my speech dramatically after a bad headache on March 30. The doctors go back and forth to whether it was a Acute Ischemic Stroke, which is what my paperwork says and a complex migraine. I do not experience migraines or anything like this ever before. I did not have a real headache on the 29th. Since my symptoms, right arm and leg difficulties are still here, my Doctor believes it was a stroke. I have an appointment with a Neurologist and I have to have another MRI. I am going to Physical Therapy. My Doctor told me to fill this out, she thinks it may be from the vaccine.

series of 2 covid pfizer vaccine 3/8/2021 and 3/29/2021 at pharmacy. next 24 hours achy body. Diagnosed with bells palsy the morning of 4/2/2021. Numbness and drooping on right side of face. Unable to blink or smile. could not eat or drink. Went to local urgent care immediately and then to hospital emergency room. was checked for stroke, determined to be bells palsy. sent home with 7 day prescription of prednisone.

Later in the evening following injection, began noticing a burning/wearing along my spine itself. Had not ever felt that before. Took Aleve and and reg Neurontin dose and applied ice packs. Eased up after a couple of hours, but to be honest, I'm not looking forward to the second dose next week if I have a repeat performance. It won't stop me from getting the shot, just a bit concerned it might be worse. Has anyone else with nerve damage to spine or other areas noticed this effect? Just curious.

very mild tremor in my right index finger/ finger underwent stronger and more pronounced tremors/the neuropathy was more pronounced; an increase in foot spasms; discomfort in my feet concurrent with an improvement in sensation in my arches; a bit more stiffness and achiness in my knees; have noticed an increase in foot spasms and discomfort in my feet concurrent with an improvement in sensation in my arches; This is a spontaneous report from a contactable consumer. A 61-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number-UNKNOWN), via an unspecified route of administration on 04Mar2021 as single dose for covid-19 immunization. Patient relevant medical history included diagnosed with breast cancer three years ago and have some chemo-induced peripheral neuropathy in her hands and feet. The patient's concomitant medications were not reported. Since getting her first shot on March 4, patient have noticed an increase in foot spasms and discomfort in her feet concurrent with an improvement in sensation in her arches. She also had several instances of a brief, very mild tremor in my right index finger, which was where most of the residual neuropathy in her hand resides; when the neuropathy was more pronounced, that finger underwent stronger and more pronounced tremors, whereas what patient had this month is negligible. Patient also had a bit more stiffness and achiness in her knees (both of which have recovered from traumatic injuries), which had mostly leveled off before my second shot but then regained some severity after the second, which was on March 23. (Yes, a 19-day cycle my shots were administered by Hospital. It was unknown if the patient received any treatment for the reported adverse event or not. It was unknown that patient was tested for COVID-19 after the vaccination or not. The outcome of the events was unknown. Information about on Lot/Batch number has been requested.

Within 1 hour severe side effects: body aches, cough (dry like asthma) , fatigue, dizziness, chills, nausea, could not sleep, Swelling, warmth, burning swellinge first dose size of 1/2 orange. No fever. Second not as severe as the first. Body aches, muscle pain, dizziness, chills, nausea, painful injection site not as much swelling,No fever. Blood Sugar spikes: 1/31/2021 280, 2/1/21 2112/27/21 319, 2/28/21 418. 9 days after second vaccine. Purple swelling of both feet. cellulitis rt foot pain worse in lt than rt .PCP to ER (soles, top lower legs black): susp tibial artery occlusion lt . Heparin. Farxiga, Ultram, baby aspirin, procardia, metformin.Possible Reynauds.Still pain discoloration and swelling.

My heart flutters; heart spasms; uncalm coming into my dreams viciously, morbidly gross; super watery bowel movement then went into clay like and drier consistency but still dark (I never had stool this dark).; I was dry/ I needed water; room seemed like it was so much further away, my stairs the spindles were larger in size, it was if I was high on something/feeling of peace, calm/high feeling; I was whistling in my breathing/ I had a loud whistle; feeling my eyes and hearing were sharp/ my eyes were changed eventually; had my eyes dilated; felt I like I was getting hemorrhoids/I woke up feeling like I had too much sugar; black stool; constipation; Chills; wanted to vomit; I got shaky; scares; There's a feeling of hardness in my lower abdomen and heart area (Belch); There's a feeling of hardness in my lower abdomen and heart area (Belch); reversed my beta blockers (it keeps it in the 50s) it went to 79; My energy was so much more.; The next day I gained 3.2 pounds then the next day lost 3 pounds; My injection site for the first 2 weeks,I had an itch/ extreme itch; injection site for the first 2 week/there's pain there on touch (no throbbing pain); My tooth broke; movement under my skin/shingles feeling; My skin is extremely dry; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. It was reported that the patient vision wasn't as good. She also had glasses to read (eyeglass wearer and ongoing) and behind her eyes they were dry one (left) mostly. Concomitant medications included unspecified beta blockers. On 11Mar2021, she got chills on the same day. Right as she got the shot, she wanted to vomit also and got shaky. On 12Mar2021, she woke up with whistling in her breathing for a few minutes then it was done. At the same moment, her eyes were changed eventually. She had mucus in my eyes as her vision wasn't as good and behind her eyes, they were dry one eye (left). So, watching TV wasn't as good and became bothersome. She later noticed, the black in here eye was taken up most of her eye (as if her eyes were dilated). Her eyes and hearing were sharp also now sharp as she was reading better (without my read glasses) and had to turn down the volume in her TV. She also felt like she was getting hemorrhoids for a few days but then it went away. She also had black stool, then constipation (harder stool) eventually went the day right after the shot (12Mar2021). Then around 5pm, she had feeling like she had too much sugar and was dry which she needed water. Once she sat down, her living room door seemed like it was so much further away, stairs the spindles were larger in size, it was if she was high on something. It was different nothing but this injection. She was also experiencing a feeling of peace and calm. As if nothing was wrong, no stress (stressing about something) she couldn't even think of- everything was gone, a calming effect. It was high feeling. The next day (13Mar2021), she had a super watery bowel movement then went into clay like and drier consistency but still dark (she never had stool this dark). In Mar2021, she also stated that there was a movement under her skin like a pre-herpes or a pre-shingles. She mentioned that she knew herpes and the movement under her skin was shingles feeling. Her skin was also extremely dry. On 17Mar2021 (a week after the injection), she woke up to my heart spasm. It was beating real fast (beating like right under her skin), no pain and heart attack but more than a heart flutter. She didn't know whether it was going to beat or stop. She also woke up with a loud whistle (louder than before) out of a dream. She stated that during the day she doesn't get the stressed, but in her dream, it was magnified and woke up in a violent vicious fury. She had 3 nights of this (uncalm coming into my dreams viciously, morbidly gross) started on 14Mar2021. The heart spasms come as a few seconds and goes away but that's happened twice which it scares her. She also stated that there was feeling of hardness in her lower abdomen and heart area (belch) in Mar2021. The injection almost reversed her beta blockers (which keep it in the 50s) it went to 79 (same as it was before she started taking beta blockers) but her blood pressure was normal 121/something (that was a good thing). She also mentioned that her energy was so much more while other people woke up early, cleaning up -would get sleepy and a little tired. But this (injection) gave her energy. Her injection site for the first 2 weeks also had an itch, that would come up (not constant) almost like a yeast infection which had an extreme itch. There's pain was there on touch (no throbbing pain) it took over a week before it was gone. She also mentioned that the chills were off and on for 4 days. The vaccine also did something to her weight as she was expecting to lose weight, but she didn't. One day, she gained 3.2 pounds then the next day lost 3 pounds. Her tooth also broke (but no pain in her tooth) even she had a sensation of her teeth being weak which she could feel it. Her tooth broke eating a tortilla chip and that's weird. She wanted to know if other people had called in with the symptoms that she had experienced. The patient recovered from breath sounds abnormal and constipation on 12Mar2021; cardiospasm, chills and vaccination site pain in Mar2021 while the remaining events were unknown. No follow-up attempts are possible. Information on the lot/batch number cannot be obtained.

dizziness; headache; fever; stomach cramps; migraine; no appetite; dry cough; fainting; stomachache; This is a spontaneous report received from a contactable consumer (patient). A non-pregnant 61-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 61 years old, administered in arm left on 23Mar2021 19:15 (Lot Number: EN6207) at single dose for covid-19 immunisation. Medical history included ongoing rheumatoid arthritis, arthrosis, osteoporosis, due to arthritis the patient couldn't eat pork because her joints get swollen. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included etanercept (ENBREL); methotrexate sodium (METHOTREXAAT). The patient experienced fainting, stomachache, stomach cramps, migraine, no appetite, dry cough on 24Mar2021 15:30, dizziness, headache, fever on 25Mar2021. The patient stopped using Enbrel and taking Methotrexate a few days prior Pfizer's vaccine. Next day on 24Mar2021, the patient had stomachache, 3rd day (25Mar2021) started with dizziness, headache and fever. Symptoms kept going after 10 days. 5 days later the patient went to the hospital and was prescribed something for stomach cramps and migraine. But the fever continued. 3 days later doctor prescribed an antibiotic since she didn't know the reason of the fever. During the course of the fever the patient had been taking Tylenol on daily basis. Fever came and went and the patient had no appetite and keep with fainting. Doctor ordered lung rx but the patient couldn't do it. 10 days later the patient had dry cough (event onset date was also reported as 24Mar2021, 15:30). The same symptoms remained. The patient did not receive treatment for all events (except fever). Events resulted in Emergency room/department or urgent care and Doctor or other healthcare professional office/clinic visit. The outcome of the all events was reported as not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.

anaphylaxis/anaphylactic condition; abnormal heart problems; vocal cord dyskinesia; SOB; extremely red all over body; Abnormal liver enzymes; Hr became Brady with widening if qtinterval; leg cramps; neuro s/s migraine severe; throat closed; Weight gain 15+ lbs on body non pitting edema; non pitting edema; extreme leg pain; breathing problems; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of bnt162b2 via an unspecified route of administration in right arm on 27Mar2021 16:45 (Lot Number: er8733, expiration date was unknown) as single dose for covid-19 immunisation. Medical history included asthma, brain disorder, arthritis, vertigo. Patient had known allergies. It was unknown if patient had COVID prior vaccination. She was not pregnant at the time of vaccination. Patient did not have other vaccine in four weeks. She used other medications in two weeks. The patient experienced anaphylaxis within 5 minutes went home extreme leg pain. Her throat closed and she had short of breath (SOB). She had extremely red all over body. She went back to emergency department (ED). Electrocardiogram (EKG), X-ray and blood work were done. She had c/o leg cramps. Her weight gain more than 15 lbs on body with non-pitting edema. She received treatment for events. She had abnormal liver enzymes, abnormal heart problems and breathing problems. Anaphylactic condition was to step down was on bipap epi (Epinephrine injection) Benadryl 50 mg every 4 hours and intravenous steroids along with fluids. Renal replacement therapy (RRT) called the next day. Patient didn't remember exact cause. Neuro s/s migraine severe Ajovy taken Uberlvy and not else remembered (as reported). Heart issues maintained and pulmonary showed improvement. Ear, nose, and throat (ENT) consult with scope done showing vocal cord dyskinesia. Heart rate became brady with widening if qt interval. She transferred to telemetry 2 d and echo done. Monitor patient for low heart rate 24 hours. Patient released from hospital on 06Apr2021 evening. At home patient continue to have organs change every 24- 36 hours keeping video monitoring and pictures. All events occurred on 27Mar2021 16:45 and resulted doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization/Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event). The duration of hospitalization was 6 days. Patient tested COVID-19 via nasal swab on 01Apr2021 with negative result. Benadryl 50 mg she had around the clock, steroids and epi used as treatment. The outcome of all events was not recovered. No follow up attempts are possible. No further information is expected.

having a stroke; I began to experience numbness on my entire left side, left arm; hand weakness, left leg weakness; trouble walking/stumbling; speech problems; slurred speech; fatigue; injection site pain; nausea; pain in my left hip; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER8727), via an unspecified route of administration, administered in left arm on 29Mar2021 16:30 at single dose for COVID-19 immunisation. The patient's medical history included chronic fatigue syndrome, fibromyalgia, sulfa allergy. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered was Pharmacy/drug store. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient experienced immediate fatigue, injection site pain, nausea, along with pain in her left hip the day after her first Covid vaccine on 30Mar2021 05:00 (Tuesday). The injection site pain resolved after a few days, but she continued to be exhausted and nauseous all week. On 02Apr2021 (Friday), she began to experience numbness on my entire left side, left arm and hand weakness, left leg weakness, trouble walking, speech problems, having to really think about her words (her daughter-in-law was typing this as she could not), slurred speech, stumbling. Her family was concerned she was having a stroke on 02Apr2021 05:00, but have no drooping in her face. She was so scared that she will not be getting her second vaccine. She have not gone to a doctor, as she do not have insurance. The symptoms were continuing. No treatment was received for the adverse events. The outcome of the event 'injection site pain' was recovered; the events fatigue and nausea was not recovered; and unknown for the rest of the events. Events were reported as non-serious. Information on lot/batch number was available. Additional information has been requested.

tachycardia (avg. 125 bpm); dry mouth; low sodium; low potassium; excruciating headache with light and sound sensitivity/head pounding; light and sound sensitivity; light and sound sensitivity; nausea; lightheadedness; My arm was sore; Felt absolutely terrible; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8734), via an unspecified route of administration, administered in left arm on 01Apr2021 13:30 (1:30 pm) as single dose for COVID-19 immunization in a clinic. Medical history included autoimmune hypothyroidism, gastrooesophageal reflux disease and don't tolerate NSAIDs but not allergic all from an unknown date. Concomitant medications included levothyroxine; esomeprazole magnesium (NEXIUM); cetirizine hydrochloride (ZYRTEC ALLERGY); gabapentin; and estradiol (ESTROGEL) all taken for an unspecified indication, start and stop date were not reported. The patient previously took erythromicin and experienced drug intolerance but not allergic on an unspecified date. The patient previously received the first dose of bnt162b2 (lot number: EN6204) on 11Mar2021 1:30 pm administered in left arm for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested since the vaccination. On 01Apr2021, it was reported that the patient experienced tachycardia (avg. 125 bpm), dry mouth, low sodium, low potassium, excruciating headache/head pounding, light and sound sensitivity, nausea, lightheadedness, arm was sore, and felt absolutely terrible. The patient was hospitalized for tachycardia (avg. 125 bpm) for 1 day. The events required physician office and emergency room visit. the patient was treated with IV saline, IV anti-nausea, and IV morphine. The patient underwent lab tests and procedures which included blood potassium: low, blood sodium: low, and heart rate: 125 bpm - tachycardia all on 01Apr2021. The outcome of the events was recovered.

severe allergic reaction to the vaccine; sore arm; neck pain; getting lots of saliva; tongue started swelling; rapid breathing, couldn't control her breathing; heart rate it got faster; started getting confused; shaky; wheezing; swelling of her throat; blood pressure dropped; This is a spontaneous report form a contactable consumer reporting for herself. A 61 years old female consumer received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; NDC number 59267-1000-01) on 29Mar2921 at 14:15, in left upper arm, for COVID-19 immunisation. No other vaccines were given on the same date or within 4 weeks. Medical history included allergic to hamsters (she found out that this one had the Chinese Hamster Ovary cells and she knew she had problems with those things), allergic to prednisone (crazy rash, itching), allergic to a lot of different things, sinus infection. Family history included allergy (the whole family had allergies). Concomitant medications included unspecified antibiotics for sinus infection (but it had cleared up by then) and unspecified allergy shots (but not a vaccine). The patient just wanted to report that she had a severe allergic reaction to the vaccine on 29Mar2021. Symptoms began minutes after getting vaccine. The patient experienced getting lots of saliva started with a couple of minutes of getting the shot, tongue started swelling, rapid breathing, couldn't control her breathing, heart rate it got faster, started getting confused, shaky, wheezing, swelling of her throat, blood pressure dropped, all on 29Mar2021. On 30Mar2021 the patient experienced sore arm and neck pain but she thought that was more of a vaccination saying it was working. Clinical course of the events included the following information: the patient had to stay for a while since she had allergies normally. She started getting lots of saliva and she thought that was her body saying, she did something, not a big deal. Around 15 minutes, she was at a grocery store, she started walking around, her tongue started swelling, rapid breathing, she couldn't control her breathing and heart rate, it got faster. She started getting confused, shaky, it wasn't too good. She made her way back to the place where the injections were done, they were trying to get her to use her epinephrine (EPIPEN). She took a diphenidramine (BENADRYL) while walking around looking for her husband and then took another and was wheezing. She thought BENADRYL would have helped. She should have taken her EPIPEN looking back, she thought BENADRYL would help. They heard wheezing, they contacted the other pharmacist, who contacted EMS then they came and took her to the emergency room on 29Mar2021 in the afternoon. When she was wheeled in, the doctor met her in the hall and he said they could give her a steroid shot. The patient stated she was allergic to prednisone, she got a crazy rash, itching, it's not just prednisone, it's an allergy. She got the shot at 14:15 and she was at the hospital by 15:00. The patient thought she was there for 5 hours and then she was sent home. Her blood pressure dropped. The only one she saw was 114/39 but her husband saw it went even lower than that. At the emergency room, they had the automatic thing strapped on so they watched her until it started going back up again. The vaccine shot was probably the easiest shot she had ever had. She had never had any problems. She did not research it very well in the beginning because she thought they should be good. The patient was told to not get the second vaccine. The events also required physician office visit. Allergic reaction symptoms resolved on 29Mar2021 but the swelling of her throat and heart rate lasted about four days, until 02Apr2021. Neck pain resolved on 01Apr2021. Sore arm resolved on 03Apr2021 or 04Apr2021. Blood pressure dropping resolved on an unspecified date in 2021. Information on the lot/batch number has been requested.

After the vaccination, I experienced pain and tingling/numbness in upper arm radiating to under the arm. Throughout the day and into the night I had pain, redness, itching and swelling at injection site. The next day (21st) a hard lump developed under the skin where I had the injection. I also had a headache and muscle aches. I didn't take any medication for the pain and discomfort as I was told it was beneficial to let the reactions occur without drug interaction or interference.

Sore arm and neck on the injection side of body.; Sore arm and neck on the injection side of body.; This is a spontaneous report from a contactable Other HCP. A 61-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9261), dose 1 via an unspecified route of administration, in left arm on 07Feb2021 13:30 (at 61-years age) as single dose for covid-19 immunisation. Medical history included diabetes, hypertension, obesity, arthritis, copd and patient was allergic to bactrin, perfume. Concomitant medication(s) included doxepin (DOXEPIN); dapagliflozin propanediol monohydrate (FARXIGA); metformin (METFORMIN); temazepam (TEMAZEPAM); dulaglutide (TRULICITY). The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.on 08Feb2021 04:00, The patient experienced sore arm and neck on the injection side of body.No treatment received for reported adverse event. The outcome of the event was resolved.

Bell's Palsy; Persistent headache; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 27Mar2021 12:00 (at the age of 61years) as single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 on 06Mar2021 12:00 (at the age of 61years) for Covid-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history was not reported. Concomitant medication included escitalopram oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported. It was reported that the patient experienced Bell's Palsy 10 days later. It was further reported that the patient had a persistent headache from date of second vaccine to now (pending clarification), including onset of Bell's Palsy. The onset date of adverse events was 07Apr2021 (11:00 AM) (as reported). The adverse events resulted in Emergency room/department or urgent care. The patient was treated with steroids and anti-viral. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was not recovered. Information on the lot/batch number has been requested.

Her platelets are 200, which is very low; Bell's palsy; Shot on the top of my shoulder; excruciating pain/shoulder pain/given high on the top of her shoulder. It hurt; sore arm; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 61-years old via an unspecified route of administration on 19Mar2021 10:10 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included systemic lupus erythematosus from 1985 and ongoing, arthritis and osteoarthritis from an unknown date and unknown if ongoing (She has osteoarthrosis throughout her body and her feet). Family history included stroke (husband died at the age of 59, he was having stroke upon stroke). The patient's concomitant medications were not reported. It was reported that when she received the shot, it was given high on the top of her shoulder and it hurt. She could not move her arm for 3 days. The pain was excruciating. On the 4th day, her arm was sore, but she could move it. She had no fevers, she didn't get sick, but she just couldn't move her arm. The shot was given at at 10:10 am, and by noon she could barely move her arm. Her left side of the mouth doesn't want to work properly. Her Bells Palsy started on 05Apr2021. She was in her car and driving to the store, when all of a sudden her left eye was watering. She got home and she didn't see anything wrong with her eye, except it was watering. She could tell a difference between the left and right side of face when she touched it. Something was wrong with her right side. Her eye was not opening all the way, it's been dropping, and her lip was down. She can't smile, and when she drinks water it's comes out. The patient clarified that it was her left side that is drooping. She went to the emergency room due to Bell's palsy. She could not move her arm within 2 hours of getting the shot. The patient mentioned her whole body aches from the Lupus and arthritis, but the shoulder pain was different after the vaccine. The shot itself hurt, and she thinks the one who administered the vaccine might have hit something. There's not a day that doesn't go by that she is not in pain. Her platelets are 200, which is very low. The patient underwent lab tests and procedures which included activated partial thromboplastin time: unknown result, blood glucose: unknown result, computerised tomogram: unknown result, full blood count: unknown result, glomerular filtration rate: unknown result; all on 06Apr2021, magnetic resonance imaging: showed a darkened area in her brain that looks like its connected with Bells Palsy on an unspecified date, basic metabolic panel: unknown result on 06Apr2021, platelet count: her platelets are 200, which is very low on an unspecified date, prothrombin time: unknown result, troponin i: unknown result (High sensitive ); both on 06Apr2021. The patient did not recover from Bell's palsy, recovered from vaccination site pain on 23Mar2021, from sore arm on 19Mar2021 and the outcome of the remaining event was unknown. Information about Lot/batch number is requested.

felt like she was going to faint; Chest pain; rapid heartbeat; high blood pressure; dizziness; Headache; nausea; could not sleep for 6 days; Heart Racing; Body shaking; This is a spontaneous report from a contactable consumer (patient) reported that a 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: en6208), via an unspecified route of administration, administered in arm right on 12Mar2021 09:30 (at the age of 61-years-old) as a single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history included asthma, blood pressure and cholesterol; all from an unknown date. The patient had known allergies. No covid prior vaccination. No other vaccines in four weeks. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR); chlorphenamine maleate, phenylpropanolamine hydrochloride (NASAMEX); simvastatine; ibuprofen; losartan; and furosemide (FUROSE); all were taken for an unspecified indication, start and stop date were not reported. On 13Mar2021 10:00, the patient experienced chest pain, rapid heartbeat, high blood pressure, dizziness, felt like she was going to faint and couldn't walk so dizzy. Her heart raced/heart racing for 5 days, headache, nausea and could not sleep for 6 days and body shaking. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received treatment for the events. Double the dose of losartan for blood pressure. Not tested covid post vaccination. The outcome of the events was recovered.

she could have partially had a stroke; She woke up and her left hand and arm were numb; left arm hurts a couple of days ago; Her hand is now cramped up, and she cannot bend it, almost like someone who has cerebral palsy.; she could not use her left hand; Her hand is now cramped up, and she can not bend it, almost like someone who has cerebral palsy./all her fingers are cramped and she cant open them and her hand is in a brace; radial nerve palsy; This is a spontaneous report from a contactable consumer or other non hcp. A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EN6198) via an unspecified route of administration, administration in left arm on 19Mar2021 as SINGLE DOSE for covid-19 immunization. Medical history was not reported. There were no concomitant medications. On 01Apr2021, she woke up and her left hand and arm were numb. She went to the hospital, and they told her she could have partially and had a stroke. Three days after receiving the first dose of the Covid vaccine, she could not use her left hand. Her hand was now cramped up, and she could not bend it, almost like someone who had cerebral palsy. She stated that after the first dose her left hand went numb, and she went to the hospital and was diagnosed with radial nerve palsy. She stated that all her fingers are cramped, and she can't open them, and her hand was in a brace. She stated that she would have to do physical therapy. It was her left hand, the same arm that she got the first dose of the Covid vaccine in. She could not move her left hand. She was really annoyed about it, and she was scared. The patient stated that she had a grandson and a daughter. This vaccine was the best possible way to prevent Covid. She had always got vaccines. Upon follow-up received on 09Apr2021, she was calling about the Pfizer Covid vaccine. She does not have a ride to get her second dose of the Covid vaccine on Saturday morning. She does not know the name of the facility where she was supposed to go. She was asking for help with an (cab service). She thought she was calling her county. She would call her county and ask for help with a ride. She had a reaction after her first dose of the Covid vaccine. She received the first dose on 19Mar2021. She does not know if it was because of the Covid vaccine. She was asking if she should get the second dose of the Covid vaccine in the same arm as last time. She wanted to get the second dose of the Covid vaccine in the same arm as last time, so that she does not mess up the other side of her body. She was asking what was going on with her arm. She was asking if thaws had anything to do with the Covid vaccine. Upon follow-up received on 09Apr2021, she scheduled second dose due on 10Apr. Her left arm hurts a couple of days ago, it ended her going to the hospital. She called to ask if it had something to do with the Covid vaccine. The event hypoaesthesia, cerebral palsy, muscular weakness, muscle spasms outcome was reported as not recovered. The event cerebrovascular accident, pain in extremity, radial nerve palsy outcome was reported as Unknown. The action taken in response to the events for bnt162b2 was not applicable. Therapeutic measures were taken as a result of her hand was now cramped up, and she cannot bend it, almost like someone who had cerebral palsy. (cerebral palsy). Follow-up (09Apr2021): This follow-up spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that: New significant information.

I took my temp, which was 100.2; anaphylactic reactions; The neck itching/burning and throat/ear pain got worse; tired; earache; swelling; itching; stinging; peeling; hurt my throat; throat was swelling; couldn't sleep; rash; burning; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 09:15 (Batch/Lot Number: EW0158) as SINGLE DOSE for covid-19 immunization. Medical history included Asthma, HBP, High Cholesterol, prediabetes. Known allergies: Penicillin, Sulfa, Peanuts. Concomitant medication(s) included rosuvastatin calcium (CRESTOR) taken for an unspecified indication, start and stop date were not reported; atenolol, chlortalidone (ATENOLOL/CHLORTHALIDONE) taken for an unspecified indication, start and stop date were not reported; metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported; sertraline hydrochloride (SERTRAL) taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On 10Apr2021, the patient experienced anaphylactic reactions, tired, earache, swelling, itching, stinging, peeling, hurt my, throat was swelling, couldn't sleep, rash, burning, the neck itching/burning and throat/ear pain got worse. It was reported that 09Apr2021- got her 1st Pfizer COVID shot. Left arm. Felt okay afterward, got a little tired later on. On Sunday, she woke up w/an earache on her left side, which moved down into her neck - near her lymph nodes. Later, her neck started swelling/itching/stinging/feeling warm, and it hurt her throat to swallow anything. She went to get Benadryl and anti-itch creams, but they didn't work. The neck itching/burning and throat/ear pain got worse, and at one point it felt like her throat was swelling and getting narrow, and she wondered if this was one of those anaphylactic reactions. So she took 2 Benadryl, and that seemed to help. That night she couldn't sleep for the neck heat, itching and throat pain. Monday AM (12Apr2021), she took her temp, which was 100.2. She did a Teladoc Zoom so the doc could see the situation, and he said that it could be a severe vaccine reaction, or some kind of infection. He prescribed prednisone & clindimycin. The rash left scars, which are peeling. Ae resulted in: Doctor or other healthcare professional office/clinic visit. AE treatment: Prescription drugs. Outcome of the events was recovering.

Tiredness; Chills; Fever; Doesn't feel good, weak; Lymph node swollen, hurts, can't touch it; Nauseous; Headache; This is a spontaneous report from a contactable consumer (Patient). A 61-year-old female patient received the second dose of BNT162B2 (COMIRNATY Formulation: Solution for injection) via unspecified route of administration as a SINGLE DOSE on 07Apr2021 02:35PM for COVID-19 immunization. The patient had no relevant medical history and family history. Patient received historical vaccine of first dose BNT162B2 (COMIRNATY) via unspecified route of administration in left arm on 17Mar2021 02:35 PM for COVID-19 immunization. Medical history and concomitant medication was not reported. No family history. Patient reported as does not think her medications had anything to do with the events. she takes all the same medications and didn't have any events with the first vaccine. On 07Apr2021 at 14:35 after second vaccine she got headache right after that and still ongoing. On 08Apr2021 lymph node under arm swollen hurts and she can't touch it and still ongoing, she was nauseous around 5 or 6 in evening. On 08Apr2021 2:00 AM she had chills, tiredness, doesn't feel good weak and fever was 100.5 then it went higher and lower. Second shot on Wednesday and she really sick was 25 percent better today. No Prior Vaccinations (within 4 weeks). The outcome of event recovered for Chills, Fever on 09Apr2021, Nauseous on 08Apr0221 and not recovered for Tiredness, Headache, Doesn't feel good, weak, Lymph node swollen, hurts, can't touch it. No follow-up attempts are needed. No further information is expected.

Left side of face is paralyzed,bell's palsy; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: ER2613), via an unspecified route of administration, administered in Arm Left on 30Mar2021 (61-years-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had no known allergies. Patient is not pregnant. Patient had no covid prior vaccination. Patient was not tested for covid post vaccination. The patient experienced left side of face is paralyzed, bell's palsy (Paralysis on the Left part of the Face) on 14Apr2021 with outcome of not recovered. No treatment was given.

passed out; tunnel vision; "jerking movements" of her upper extremities; left arm was tingling/left pinky and ring fingers felt nerve tingling sensations; then the back of her throat had a chemical taste and tingling; then the back of her throat had a chemical taste and tingling; BP was 164/94 while lying down; continued to have pain in her left arm and across the left side of her chest and left-sided back shoulder; continued to have pain in her left arm and across the left side of her chest and left-sided back shoulder; continued to have pain in her left arm and across the left side of her chest and left-sided back shoulder; tongue was tingling and felt swollen with an altered chemical taste for 2 days; tongue was tingling and felt swollen with an altered chemical taste for 2 days; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 12Apr2021 11:00 (Lot Number: ER8734) at the age of 61 years old as single dose for covid-19 immunisation. Medical history included Low thyroid, kidney infections, skin rashes, high cholesterol, food sensitivities. Concomitant medications in two weeks included liothyronine sodium (CYTOMEL); levothyroxine; vitamin b complex (VITAMIN B); levoglutamide (L GLUTAMINE). Facility type vaccine was Pharmacy or Drug Store. No other vaccine in four weeks. On 12Apr2021 11:00, within 1st min of vaccine, the patient's left arm was tingling, then the back of her throat had a chemical taste and tingling, then tunnel vision, then that was the last thing she remembered until she heard her partner saying, "Are you ok?" The patient said to her she thought she fell asleep. She was an RN and said that the patient passed out for about 15 seconds and had "jerking movements" of her upper extremities before she woke up. The staff and medic helped the patient to the floor where she rested for 20 min with her legs elevated on chair. BP was 164/94 while lying down, pulse was 74. The patient returned home and continued to have pain in her left arm and across the left side of her chest and left-sided back shoulder for most of the day. Also her left pinky and ring fingers felt nerve tingling sensations for the rest of the day. Her tongue was tingling and felt swollen with an altered chemical taste for 2 days. No treatment received for the events. No covid prior vaccination and no covid tested post vaccination. The outcome of the events was recovering.

heart was racing; tingling feeling; passed out; dizzy; queasy; I am diabetic; sick; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 10Mar2021 (Lot Number: EN6201; Expiration Date: 30Jun2021) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included 1st dose of BNT162B2 (lot number: EN9581, Expiry Date: 31May2021) on 17Feb2021 and 13 days later patient started feeling sick and wholly got sick. Patient went for the second vaccine and passed out as she got the vaccine right there in the hospital (10Mar2021), so they gave her the vaccine and then patient sick for the next three weeks 3 and half weeks. The first-time patient passed out they took her to the emergency room for whole afternoon on 10Mar2021 because patient was so dizzy and queasy and she guessed they did like 'A1C' on her. They made sure that took blood for her they made sure patient was diabetic. They wanted to make sure there was nothing wrong with patient and then they sent patient home at same afternoon and patient went home and another whole week she was so dizzy and nauseous and now she was tingling feeling. All kind of weird things happened to patient and her heart was racing. Patient took herself back to the hospital after a week. Patient had to stay in the hospital for two days. And then they did MRI on her and a CAT scan and then they sent patient to neurologist and then patient to do another MRI. Patient been for past six weeks was being turmoil. Outcome of the events was unknown.

severe vertigo; fall down on the floor; nausea; horrible spinning; vomited; dizzy; generalized weakness; brain fog; a little tired; a little off; Fatigue; sore arm; couldn't eat; couldn't open her eyes; nystagmus; couldn't walk at all without help; This is a spontaneous report from a contactable consumer, reporting for herself. A 61-year-old female patient received the second dose of the bnt162b2 (BNT162B2; Lot Number: EN6208; Expiration Date: Jun2021), via an unspecified route of administration in the right arm on 19Mar2021 at 13:30 at a single dose for covid-19 immunisation. Medical history included ongoing celiac disease diagnosed in 2012 and has been gluten free ever since, allergies, and anxiety. Concomitant medications included zolpidem tartrate (AMBIEN) taken for sleep; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for allergies; alprazolam (MANUFACTURER UNKNOWN) taken for anxiety; vitamin d nos (MANUFACTURER UNKNOWN) taken for immune system health; and magnesium (MANUFACTURER UNKNOWN) taken for health. The patient previously received the first dose of the bnt162b2 (Lot number: EN6203) at 61 years of age on 26Feb2021 between 5:15PM and 5:30PM in the left arm at a single dose for covid-19 immunization and the flu vaccine (INFLUENZA) for immunization 15 years ago and experienced arm was sore. There were no other prior vaccinations within 4 weeks. On 19Mar2021, the patient experienced sore arm. On 21Mar2021, the patient experienced a little off, fatigue, brain fog, a little tired. On 31Mar2021, the patient experienced severe vertigo, fall down on the floor, nausea, vomited, horrible spinning, generalized weakness. In 2021, the patient experienced couldn't open her eyes, couldn't eat, nystagmus, could not walk at all without help. On an unknown date, the patient experienced dizzy. The events, severe vertigo, fall down on the floor, nausea, vomited, and horrible spinning, required emergency room and physician office (video) visits. The patient was hospitalized for severe vertigo, fall down on the floor, nausea, vomited, and horrible spinning from 31Mar2021 to 02Apr2021. The clinical course was as follows: the patient received the second dose on 19Mar2021 and she didn't really have any bad side effects, a sore arm, and a little tired on the second day, maybe a little off but was fine. 12 days later she was vacuuming and had severe vertigo, she was down on the floor, just horrible spinning, horrible nausea and laid on floor and vomited all day. Her doctor told her to go to the ER. They did all kinds of tests with unknown results on an unknown date and she could not open her eyes for 2 days, she was so violently spinning with vertigo, they gave her fluids. She went in on Wednesday and by Friday she was a little better, she could open her eyes, still had spinning and vertigo. It was like nystagmus, her eyes were, she just really couldn't open her eyes for the doctor, had generalized weakness and couldn't walk at all without help in the hospital. The only time she moved from one position was to go to the bathroom with assistance. In the ER, she could not get up out of bed the first night they were trying all ways of catharizing her. She could not even get out of the bed with the help, they had to carry her to the CAT scan with negative result on 31Mar2021. She had slightly improved but still had vertigo and she was not vomiting anymore, that was only the first couple days. She was sent home with medications for dizziness and nausea but they didn't do anything. Two weeks later she was still dizzy, had vertigo, it was way better than it was, she can open the windows a little bit but she was basically in a dark room for like the first week and a half. Not violent like it was the first couple of days. The events were further described as: she was a little sore on 19Mar2021, 20Mar2021, 21Mar2021, and maybe the 22Mar2021 her arm was still sore. She clarified the sore arm pretty much ended on the 22Mar2021. She was surprised she felt fine on 19Mar2021 and 20Mar2021 and on the evening of 21Mar2021, in the middle of the night between 20Mar2021 and 21Mar2021 she felt a little off and a little more tired. On 21Mar2021, she didn't feel great, fatigued and brain fog but was fine after that. She began feeling a little off and a little tired early morning on the 21Mar2021. That was pretty much gone by the 22Mar2021. The feeling tired and a little off and the brain fog and fatigue went away 22Mar2021. She vomited constantly, started suddenly and violently and was incapable of moving, all she did was vomit and lay on the floor. It was a complete 360, she was fine vacuuming a minute before and then suddenly got dizzy and went down and could never get up. She had to be taken from upstairs in her house and transported to the hospital. She was not really experiencing the nausea now, she was not completely herself but she can eat, she couldn't eat for the first couple of days and was on IV fluids and once she got out of the hospital was able to eat a little and now eating almost normally. It took a week to eat normally and she couldn't eat holiday dinner on 04Apr2021. From 31Mar2021 to 10Apr2021, every day the nausea has slightly been improving. She was not quite herself and still has vertigo and was making herself eat her meals. She vomited 30 times and in the hospital they gave her an IV to stop that and never vomited in hospital, maybe once in the ER. She confirmed the 31Mar2021 was the last time she vomited. She had not recovered completely from nausea. She used be running around all the time, she would walk 10 miles per week to exercise, yesterday she had a mammogram scheduled and she was just so wiped out for doing something for the first time and had to lie down for the whole rest of the day. She was hospitalized from 31Mar2021 until the evening of 02Apr2021 when they let her out. She was given medication for nausea and dizziness didn't do anything. She was given ondasetron (ZOFRAN), 4 mg and meclizine. Because of her weakness, the patient was checked to see if there was any brain bleed or brain stem problems that would explain the vertigo and did not find anything. The tests were negative for any brain problems on an unknown date. Lab data included: blood levels: low on vitamin d (probably because she was not absorbing nutrients as well) on an unknown date, endoscopy: unknown results on an unknown date, and MRI: negative on 01Apr2021. Therapeutic measures were taken as a result of severe vertigo, fall down on the floor, nausea, horrible spinning, vomited, and dizzy. The clinical outcome of the events, severe vertigo, nausea, generalized weakness, could not open her eyes, nystagmus, could not walk at all without help, was recovering. The clinical outcome of the events, fall down on the floor, horrible spinning, dizzy, was unknown. The clinical outcome of the events, a little off, fatigue, sore arm, brain fog, and a little tired, was recovered on 22Mar2021. The clinical outcome of the event, vomited, was recovered on 31Mar2021. The clinical outcome of the event, could not eat, was recovered in 2021. No follow-up attempts are needed. No further information is expected.

Feeling like maybe there is something wrong with her spleen; The pain is in the left side of the back kind of by the lungs; She has been sick; Her mental status was also affected; What scared her was not feeling like she was getting enough oxygen; Nausea; Body pain/flu-like body pain in her muscles over her shoulders; Out of it; Pain in her back where her lungs are; Problems breathing/Her breathing still almost feels labored; Hot and cold sweats; Dizzy; Shaky; Weak; Tired; Headache; Anxious; Fever; Itchy; Arm hurt; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer. A 61-year-old female patient received first dose BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 09Apr2021 13:00 (Batch/Lot Number: TW0151) as SINGLE DOSE for covid-19 immunization. Medical history included cancer, pneumonia, pain in her lungs, smoker and arthritis. The patient's concomitant medications were not reported. The patient experienced what scared her was not feeling like she was getting enough oxygen on an unspecified date, problems breathing/her breathing still almost feels labored on 11Apr2021, arm hurt on 09Apr2021, pain in her back where her lungs are on 11Apr2021, hot and cold sweats on 10Apr2021, dizzy on 10Apr2021, shaky on 10Apr2021, nausea on 13Apr2021, body pain/flu-like body pain in her muscles over her shoulders on 11Apr2021, out of it on 11Apr2021, weak on 10Apr2021, tired on 10Apr2021, headache on 10Apr2021, anxious on 10Apr2021, fever on 10Apr2021, itchy on 09Apr2021, feeling like maybe there is something wrong with her spleen on an unspecified date, the pain is in the left side of the back kind of by the lungs on an unspecified date, she has been sick on an unspecified date, her mental status was also affected on an unspecified date. Patient had the first dose of the Covid Vaccine on 09Apr2021 and gradually her arm hurt, she had hot sweats, she felt dizzy, was shaky, had nausea, and had body pain. The one thing she is concerned about was she had pain in her back where her lungs are and she was having problems breathing. She has a little bit of that still. She has also been out of it. Her breathing still almost feels labored, and this past weekend she thought she would go to the emergency room. Her main concern is this awful pain in her back while she was having problems breathing and getting enough oxygen. She felt weak, dizzy, and shaky. She got scared. She has been sick, she had cancer a long time ago. What scared her was not feeling like she was getting enough oxygen. The pain is in the left side of the back kind of by the lungs. It goes directly from the front to the back. On Monday it started feeling better. Today it is so much better. She will feel like she is not getting enough oxygen or giving a full breath and then this in her back. She remembers having pneumonia years ago and having pain in her lungs. That's why she knows the pain is in the back of her lungs. She has to say she is a smoker. She slowed down and couldn't smoke this week or during that. She kind of quit, that's her reality now. The pain comes and goes throughout the day but it is not as bad. She didn't have this shortness of breath and other things until a couple days after she got the vaccine. It gradually came up on her. She was not having trouble breathing, it was more slightly labored. It was not profound, just there. Sometimes when she is speaking after a while she gets tired and will have to take a moment and take a deep breath. It is so much better. She called her primary care physician and was anxious, and all he said was she would feel effects for 2 weeks. He wasn't very helpful. Her arm hurt the day that she had the shot. Even today there are little bits of pain but very light. 09Apr2021 through 11Apr2021 was when everything really hit. It was hard to lift up her arm. It was a little pain, it was no big deal. She would have the AC on and blast it when she had the hot and cold sweats. She was using napkins because she was sweating profusely. It felt like she obviously had a reaction to the vaccine. It's normal she guesses. She didn't expect it for the first dose. The 11th, 12th, 13th, and 14th it was really bad. Her whole body was sweating and would get wet. She'd be hot and then cold. She was anxious because she was having problems breathing. She still gets a little bit of hot and cold sweats, but nothing compared to what she went through. As the days go on she is slowly getting better. She was dizzy not just during the day, at night she couldn't sleep because of it. She has gradually gotten better. Yesterday she tried to do some gardening but felt so weak she had to come back inside. When she gets up she feels weak and a little bit of lack of air. She has labored breathing. She was real itchy. The shakiness, dizziness, and anxiety all came on and were horrible. She doesn't know if the nausea was because she couldn't eat and had to take her regular medication. It was very light nausea. She had flu-like body pain in her muscles over her shoulders. Her headache was major too during all of this. The headache is something that comes and goes still. It is a weird kind of headache. She had a fever and got like flu all over body pain. She doesn't know how to explain how she felt out of it. She doesn't know if it was the fact she was so sick. She had a feeling of did she do that. She couldn't make decisions. She would need to take the garbage out and go back to the garbage and think what did she come here for. Her mental status was also affected. The weakness gradually got really bad, and she still hasn't recovered from it. She still feels weak and tired when trying to do things. She was tired the day after she got the vaccine. The first day she thought it was nothing and she was fine. Gradually it got real bad when she was sick. She didn't feel that flu-ish feeling but was weak and tired. She got dizzy and she had the brain fog thing. She was having really bad headaches during the same time. The weakness and tiredness go hand in hand. She takes a mineral for her thoracic spine, but she takes that more for elderly arthritis. She doesn't have any conditions that she thinks played a role. She has been feeling like maybe there is something wrong with her spleen. Took Tylenol for her fever. Mentioned fever would go away and come back. The patient underwent lab tests and procedures which included body temperature: 102, 99 and 100.1 (unit unspecified) all on unspecified dates. Therapeutic measures were taken as a result of fever and itchy. Outcome of the event problems breathing/her breathing still almost feels labored, arm hurt, pain in her back where her lungs are, hot and cold sweats, dizzy, out of it and headache was recovering. Outcome of the event fever was recovered on 13Apr2021, itchy was recovered with sequelae on 14Apr2021, body pain/flu-like body pain in her muscles over her shoulders was recovered on 16Apr2021, nausea was recovered on 16Apr2021, shaky was recovered on 19Apr2021. Outcome of the event weak and tired was not recovered. Outcome of all the other events was unknown.

Very late diagnosing as shingles; Headache at work after vaccine; then got more severe along with leg very sensitive and burning feeling; then got more severe along with leg very sensitive and burning feeling; severe stomach pain; This is a spontaneous report from a contactable other HCP (patient). A 61-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration, administered in Arm Left on 28Jan2021 09:00 (at 61 years old), single dose for covid-19 immunisation. Medical history included concussion, endometriosis, all from an unknown date. Concomitant medications included estradiol; progesterone. No other vaccine in four weeks. On 28Jan2021 09:00, patient experienced Headache at work after vaccine , then got more severe along with leg very sensitive and burning feeling, better then 5 nights very severe stomach pain-Dr appt and ER to get sonogram, CT-Very late diagnosing as shingles. The outcome of the events was not recovered. Treatment of adverse events was CT, Sonogram. No covid prior vaccination. Not covid tested post vaccination. No Known allergies. Information about lot/ batch number has been requested; Sender's Comments: Based on known disease pathophysiology, the event herpes zoster is assessed as not related to suspect vaccine BNT162B2.

1st and 2nd dose- swollen glands; injection site pain in right arm; 2nd dose- shingles/shingles blisters; felt quite ill/not feeling well; second dose- extreme pain in left hand/sore arm; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Right on 08Mar2021 (Batch/Lot Number: EN6208) (at the age of 61-years-old) as 2ND DOSE, SINGLE for COVID-19 immunisation. Medical history included breast cancer (2-time breast cancer survivor), had lymph nodes removed, and has low thyroid. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for low thyroid from an unspecified start date and ongoing; ascorbic acid, betacarotene, biotin, calcium, chloride, chromium, copper, folic acid, iodine, iron, magnesium, manganese, molybdenum, nickel, nicotinic acid, pantothenic acid, phosphorus, potassium, pyridoxine hydrochloride, riboflavin, selenium, silicon, thiamine, vanadium, vitamin b12 nos, vitamin d nos, vitamin e nos, vitamin k nos, xantofyl, zinc (CENTRUM SILVER WOMEN 50+) taken for an unspecified indication from an unspecified start date and ongoing; acetylsalicylic acid (BABY ASPIRIN) taken for an unspecified indication from an unspecified start date and ongoing; colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for an unspecified indication from an unspecified start date and ongoing; famotidine (PEPCIDAC) taken for an unspecified indication from an unspecified start date and ongoing; esomeprazole sodium (NEXIUM) taken for an unspecified indication from an unspecified start date and ongoing. Patient previously took shingles vaccine on an unknown date (reported as number of years ago) for immunization, flu shots on an unknown date for immunization and also previously took the 1st dose of BNT162B2 (Batch/lot number: EN6200) (at the age of 61-years-old) on 15Feb2021, intramuscular administered in the right arm for COVID-19 immunisation, and experienced injection site pain in right arm, sore arm and swollen gland. Patient stated having what was considered typical, like a sore arm and did have some swollen glands with the first and second dose. It was also reported that after 1st and 2nd dose, there was injection site pain in right arm. After second dose she developed shingles, or what was later found out to be shingles, she had extreme pain in her hand. She thought it was injured or something, it was very painful. She got shingles blisters on her hand, and then also got some on her arm, the opposite arm as the injection. Her dermatologist and internist verified it was shingles. Her internist said it may have been triggered by the vaccine. She clarified it started in the palm of her hand and then traveled up her arm on the opposite side of the vaccine, she got the vaccine in the right arm and the shingles in the left arm. She felt quite ill as a result of the shingles. Her dermatologist put on Valtrex, three times a day. It helped with the spread; it stopped spreading. Her dermatologist was not associating it with the vaccine, and she was not sure she was either. After not feeling well for several days she told internist and he was confident that the vaccine was what caused the shingles. She doesn't remember for sure the event extreme pain in left hand, but it was within a few days after the 2nd dose. The swollen glands started within 24 hours, as well as, the sore arm. It wasn't anything she didn't expect. Like with the flu shot maybe a little worse, but it wasn't severe. Her sore arm was not ongoing. It recovered completely by the next day. Swollen glands came back when the shingles first happened, but they initially began within 24 to 48 hours, for both doses. After the second dose she took two extra strength Tylenol again on the first night again; she just took it once after the 2nd dose. Pain in the hand was 98 to 95 percent better. Her doctor did whole blood work up (unknown results) just to see her white count (unknown results) to rule out something else. The blisters were too small for the dermatologist to scrape and get a biopsy. She did not get the most current 2 dose vaccine for shingles, she only got one dose and that was a number of years ago, she was going to get it but then COVID happened. The outcome of event herpes zoster and pain in extremity was resolving while for other events was unknown. No follow up attempts are possible. Information about Lot/batch number cannot be obtained.

REACTION OCCURED 8 MINUTES AFTER VACCINE, CHEST TIGHTNESS, FLUSHED AND DIAPHORETIC, 97.9, 165/83, 77. 25MG BENADRYL GIVEN.

Severe left upper extremity pain and fatigue for two days after that I took two Tylenol?s and all the symptoms subsided

Approximately 12 hours after injection, sudden onset headache, went to bed and woke a couple hours later with severe back pain, neck pain, deep muscle ache in legs, low grade fever. 24 hours after injection, some decrease in pain with Tylenol, diarrhea, fatigue, general malaise. Loss of taste, loss of appetite . 48 hours post injection- subsiding muscle aches, other symptoms on going, 72 hours post to present, diarrhea, loss of appetite

Arm was sore for about three days. On 12/21 evening, had headache, some lightheadedness and severe back muscle ache. On 12/22, had stomach upset, extreme fatigue, nasal congestion. On 12/24, had diarrhea. Fatigue continued until at least 12/29.

fast heart beat; it was like she didn't feel good; low grade fever; nausea; headaches; chills; sore arm /arm soreness; tired; felt like she had a flu; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization. Medical history included Diabetes, allergies, heart (Heart disorder). Concomitant medications included irbesartan (AVAPRO) for heart, cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for allergies, metoprolol for heart, metformin for Diabetes, all were ongoing. The patient (Hospital scheduler/employee) had been experiencing side effects of the vaccine. She took the vaccine on 18Dec2020 and still experiencing nausea, headaches, and chills. She asked how long she would experience these side effects and if she needed to take anything. Patient reported she was exposed to someone who had COVID, her son's girlfriend had direct exposure to COVID and wanted to know how it would affect her. The patient further stated she was a hospital scheduler, she had the Pfizer Covid vaccine on 18Dec2020. She had a sore arm/arm soreness and was tired immediately after (18Dec2020), stated by Saturday 19Dec2020, she started having a low-grade fever, chills, headache, nausea, and still had the soreness in the arm. This went on for 2-3 days. Patient stated that up until now, she still had nauseous feeling that happened intermittently around early morning or mid-day, the chills were midday to early evening, it was like she didn't feel good, had to leave early from work. The fever only lasted a couple of days. She also had one isolated episode of fast heart rate that woke her up in the early hours of Sunday 20Dec2020. Caller stated she expected some of these effects to only last a couple of days but wanted to know if this was normal. She tried working 2 days last week and by mid-day she was just really tired, like she was about to get the flu, she felt like she had a flu just with no respiratory symptoms (De2020). She knew of one other coworker who was experiencing similar symptoms. No patient identifiers were provided, no further information provided. Patient did have history of allergies from when she was a child and was on medication, she was on over the counter medication Zyrtec for years, she didn't know if there could be a conflict between them. She received her vaccine part of the hospital. She also called because her son and his girlfriend live in her house and his girlfriend was exposed to someone who tested positive for Covid, she wanted to know how this may affect her since she had the vaccine. Investigation assessment was no. The outcome of the event "sore arm /arm soreness" was recovered in Dec2020, of "low grade fever" was recovered on 21Dec2020, of the events "tired", "nausea", "headache" and "chills" was not recovered, of the other events was unknown. Information about Lot/Batch number has been requested.

1/2/21- 1/5/21 Fever, chils, arthralgias, swollen throat, nausea, BLURRY VISION, RED eyes, white noise in ears, fatigue lacinating pain ankles, knees ,wrist and finger joints; pain along nerves and vessels fingers with right fourth DIP ulnar side small vessel bleed hematoma 4 cm x 4cm swelling; NO trauma sedenatry Saw Urgent care 1/4/21 -with negative covid 19, strep and flu tests said was repsonse to vaccine Saw primary 1/5/21 Dr hopsital, said probably had covid before and was repsonse to vaccine. 1/6/21; all fingers still swollen no pain most other symptoms improving but TIRED

Patient reports hot and cold flashes and felt that she may pass out, she went to ER and everything else is okay

swelling and joint pain in the little finger on left arm; swelling and joint pain in the little finger on left arm; She got a bruise at the injection site; It bled a little bit when she put it in; This is a spontaneous report from a contactable nurse (patient). A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK9231), via an unspecified route of administration on the left arm, on 28Dec2020 at 14:15 at a single dose for Covid-19 immunization. Medical history included environmental allergies, she has allergies and can have an asthmatic attack from cat dander and perfume, blood pressure (abnormal) and sleep (disorder). Concomitant medications included ongoing lisinopril for blood pressure, colecalciferol (VITAMIN D), acetylsalicylic acid (BABY ASPIRIN), paracetamol (TYLENOL). The patient previously took novocaine but was allergic. She got all this information when she got the vaccine on Monday at (place name) in (state name). It tells all the side effects from the first injection. She wanted to report that it is the same arm that she got the vaccine in. She has swelling and joint pain in the little finger on left arm. It says you can have joint pain, but nothing about swelling. She thought she better report it. This was her first shot. She is supposed to get the second one on 18Jan2021. She wanted to make sure she can take it. She received the vaccine on 28Dec2020. She laid around that day. Today is the first day she doesn't have arm pain and swelling at the injection site. It was the first time she has had arm pain. She has never had that with flu shot. The arm pain started within the 15 minutes she was observed. It hurt like hell until that day. She got a bruise at the injection site. It bled a little bit when she put it in. Swelling and joint pain in the little finger on left arm: she doesn't know if it was later that day. She can't remember. She really noticed it yesterday. She has never had joint pain or swelling. She doesn't have any problems with arthritis. Now her little finger is bigger than the rest of her fingers. It hurts because of the swelling. She doesn't want to take anything. It might be fluid. She has a high pain tolerance. She keeps bending it thinking it will get better. It isn't as bad, but its still swelled up. At first she thought it was better, but it is still pretty swollen. To her this is a reaction. She was thinking if she took paracetamol before, it wouldn't hurt as bad, but she can't remember if she took it that morning. She takes 500mg before bed for the heck of it at night. It helps her sleep better. She has allergies and can have an asthmatic attack from cat dander and perfume. They think she was allergic to the preservative in the flu shot, but she has never had any trouble with the flu shot since. She has environmental allergies. They thought she was allergic to Novocaine once at the dentist office. Who knows, it only happened once. She's been to the dentist many times and who knows what they injected and why she reacted that way. She felt like she was going to pass out. They don't give it to her anymore. She doesn't know what was in it. She is worried since this vaccine is emergency authorization. She doesn't want to get the next one and have a worse reaction. She is not sure if she should be worried. The events of swelling and joint pain in the little finger on left arm were assessed as medically significant. Outcome of the event of 'swelling of fingers' was not recovered, the other events were unknown.; Sender's Comments: There is a reasonable possibility that the event joint pain was related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the event swelling with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

I had the 1st Pfiser Covid Vaccine on 12/21/20 and on 12/24/20 I had abdominal pains resulting in diarrhea turning into bright red bleeding by the late morning on 12/25/20. I continued to bleed for hours (only when cramping) and ended up going to an ED for severe abdominal pain, bleeding, nausea and general weakness. The ED doctor said it was from internal hemorrhoids and the diarrhea and was not sure it was related to the Covid Vaccine and possible being an intestinal flu but I felt like I needed to report. I also had nausea and vomiting the evening of 12/26/20 lasting about 12 hours. It took me a few days of Zofran and Imodium to get it in control and the bleeding did stop by 12/27/20.

10:23pm felt a slight headache and nausea. Left work at 10:43pm since didn't feel good. While on road, my tongue started to tingle and then my lips started to tingle and both sides of face felt numb. This started around 10:50pm? Went to bed and woke up Sat with same tongue, lip tingleling and face numbness. Lips felt very swollen. Felt that way throughout the weekend. On Monday, went back to work place injection area and requested someone talk to me. Nurse practioner came out and spoke to me, asked about balance of facial features, no problem breathing or swallowing and gave me 25mg benadryl to take 3 times a day. Did nothing but make me sleepy. She calls me Tue am and told me to make an appt with PCP. Made phone appt for Wed. Dr calls me Wed am and gives me presciption for 60mg Prednisone to take for a week (at this time symptoms are the same). the first 3 days taking Prednisone the intensity of tingleling seems to lessen day by day. But on 4th day, the symptoms stopped lessening. Finished the meds anyway. Last 3 days, i've also had that mild headache back in addition to the numbness from face traveling up to my ears. Past few days the tingling in tongue isn't confined to just the edges of the tongue. It started with the first 1/4 of whole tongue and is today tingleling in the front half of whole tongue. One good thing so far is the past few days, my lips feel way less swollen and tingleling is lessening. So, riding this out, hoping it will end sometime this year. Will not be getting the second shot. Just so you know.

Back pain; Muscles felt really tightened up and stiff when getting out of bed and throughout the day (worst complaint); slight nausea/nausea; slight fatigue; slight headache; slightly stiff neck; right arm pain; The muscles knot up under her rib cage/muscle tightness; This is a spontaneous report from a contactable other health care professional. A 62-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL1284), intramuscularly in the left arm on 29Dec2020 at 06:30 at a single dose for COVID-19 immunization. Medical history included Hashimoto's thyroiditis from an unknown date and unknown if ongoing. Concomitant medications included ergocalciferol (VIT D), levothyroxine (MANUFACTURER UNKNOWN); both taken for an unspecified indication from an unspecified date to an unspecified date. The patient previously took sulfamethoxazole and trimethoprim (BACTRIM) and experienced allergy from an unspecified date to an unspecified date, influenza vaccine (FLU VACCINE) for an immunization on an unspecified date (received within two weeks of vaccination). The patient experienced the following events and outcomes: muscles felt really tightened up and stiff when getting out of bed and throughout the day (worst complaint) (non-serious) on 30Dec2020 at 07:00 with outcome of not recovered, slight nausea/nausea (non-serious) on 30Dec2020 at 07:00 with outcome of not recovered, slight fatigue (non-serious) on 30Dec2020 at 07:00 with outcome of not recovered, slight headache (non-serious) on 30Dec2020 at 07:00 with outcome of not recovered, slightly stiff neck (non-serious) on 30Dec2020 at 07:00 with outcome of not recovered, right arm pain (non-serious) on 30Dec2020 with outcome of unknown, back pain (non-serious) on 31Dec2020 with outcome of unknown, the muscles knot up under her rib cage/muscle tightness (non-serious) in Dec2020 with outcome of unknown. The patient received the COVID-19 vaccine on 29Dec2020 at work, and she had been experiencing adverse events since. The worst side effect she was experiencing was muscle tightness. At the time of the report, the patient got up at 09:00, and her "back was killing her." The patient was achy. The patient would tighten up really tight under both rib cages, and it made her nauseous. The patient had been taking ibuprofen (ADVIL) and ibuprofen (MANUFACTURER UNKNOWN since she received the vaccination. The patient received the vaccine in her left arm, but her right arm hurt the next day. The next day after that (30Dec2020) she woke up and the right side of her back around the kidney area hurt. It was the right side lumbar. The next morning after that, "her entire back was killing her down the middle of her spine. From her head all the way down." Since then, it came and went. The patient could not say if it was persisting, improving or worsening for any of the symptoms. "It just grabs her." The day before the report, the patient thought she was doing better. The patient cleaned the house, and then sat down to eat. The past two nights, it had "hit her really hard during supper time." Both of her sides of her back would tighten up; "tense up like waiting for an impact before a wreck." The patient's back would seize up. The patient could not get comfortable; and would start pacing. Then, she would try to lay down. Last night, it took a half an hour to loosen back up. "It knots up like crazy. It was bad enough, she thought she was going to pass out." The patient did not know if it was the combination of eating supper or what. The patient thought if she got up that maybe she would feel better. The patient started pacing around. The patient went outside because she thought maybe fresh air would help. When it would tighten up under her rib cage, it made her nauseous. The patient did not know if it was a "vagus nerve thing or what." The patient was close to throwing up. The muscles knot up under her rib cage. The patient's back felt like she fell off a horse. It was weird to her that her left arm never bothered her. "Nothing stays the same." Sometimes it was her entire arm or part of the arm that hurt. Like on top of her forearm. The patient thought she was doing good and then it would come back. When she moved her arm upward, she felt it. The patient said she could deal with the arm pain. It was the knotting up pains that were the worst. The patient tried calling an institute (name withheld) because it happened while eating dinner the other night. The institute (name withheld) "nurse was useless." The pain was across her sacroiliac area. The patient had been "living on Advil and ibuprofen for her back pain." The patient had been taking them together. The patient worked nights, and she was planning on going to work the night before the report, but she had to text her boss and tell her she could not come in. The patient was in good health; had perfect blood pressure and her sugar was normal. The patient was not diabetic. The patient's labs were always normal. The patient was really dreading that second shot. "The flu shot kicked her butt for a couple of days, but this was way worse." The patient started reading up on the COVID vaccine, and it said usually younger people had severe side effects. That old people have less of a response. The patient did not know why she was experiencing such side effects. At the time of the report, it was day 7 or 8, and she was still feeling bad. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.

My body had started itching and I didn't know why. I had not eaten anything new or changed any shampoo or soap. Finally on Thursday night I realized maybe it is the shot that is giving me all the itching. My whole body was flushed I kept scratching my arms and legs, especially around my ankle, knee, under arm and goin area. I took an allergy pill and called Kaiser and spoke with an advice nurse. she mentioned that taking an allergy pill will relief some of the itching. I fell asleep around after midnight normally I go to bed around 9:30. I also called pfizer and explained and the person took all my information and symptoms.

Pfizer-BioTech COVID-19 Vaccine EUA 24 hrs post vaccination I started feeling fatigued, muscle and headaches which seemed to move around my body for about 24 hrs. At one point it seemed to settle into my hand. Knuckles swelled arthritis like. When walking up stairs I had significant muscle weakness in my legs and exertional dyspnea. Eyes felt "feverish" but had no fever. The next morning while trying to do a routine workout the same thing happened. It was a significant change to my normal condition. The dyspnea was the most concerning. The body aches settled into my lower back. Fatigue was moderate-moderately severe. As the day went on things waxed and waned. By the end of 72 hrs. most symptoms subsided. Friday 01/08/2021 I had a completely normal workout, no exertional dyspnea, fatigue subsided, no body aches. Back to normal. I would consider the symptoms to have been Moderate+.

Tachycardia (HR in the 110s), felt warm, forearms visibly flushed, nausea 20 min post vax Observation and fluids Sxs resolved after 15 mins of close monitoring NKA

Tested Positive for COVID-19/nausea, occasional dry cough, neck and lower back soreness, and sore throat; Tested Positive for COVID-19/nausea, occasional dry cough, neck and lower back soreness, and sore throat; Weakness/generalized weakness; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received first dose of BNT162b2 (Pfizer, Lot number: 5730), via an unspecified route of administration at right arm at 22Dec2020 21:00 at single dose for covid-19 immunization. Medical history included Mayonaise allergies. The patient's concomitant medications were not reported. The patient previously took codeine and experienced allergies. At 31Dec2020 06:00, the patient experienced Weakness, nausea, occasional dry cough, generalized weakness, neck and lower back soreness, and sore throat which has now dissipated. Tested Positive for COVID-19 on 02Jan2021 (also reported as 01Jan2021, pending clarification). The covid test type post vaccination was Nasal Swab, Covid test name post vaccination was COVID-19 PCR ROCHE c6800(NTX), RNA SARS CoV2 TGT1, PAN SARS RNA TGT2. No treatment received for events. The events result in Emergency room/department or urgent care. The patient was not pregnant. The outcome of the events were nor recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded. The case will be reassessed if additional information becomes available.

About 13 hours after injection I started having extreme chills and shaking. Took 2 Ibuprofen and the chills subsided during the night and then had mild/moderate body aches for about another 12 hours. About 48 hours after the injection the top half of my arm is currently slightly swollen, red and hot to the touch.

Eight hours after vaccine I developed terrible chills fever, terrible myalgia and weakness . The pain was terrible as was the fatigue and fever . I used Ibuprofen. 48 hours later I felt almost completely normal- no pain etc . Then 56 hours later resumption of chills fever for 4 hours . At 64 hours and after ibuprofen feeling better

Starting on 01/09/2021 at 02:00am woke up nauseous and hot. Body aches especially r arm with tingling in r hand, dizziness and chills throughout the day They would come and go. Late afternoon, Biceps went into spasms all fingers aching. After nap at 06:00 woke up and all symptoms gone. On 01/10/2021, woke up with tingling and burning from bilateral knees to toes. Lasted 2 hours and then gone. In afternoon 1 episode of dizziness and hot flashes followed by chills. 01/11/2021 Slight headaches. No bodyaches or other symptoms.

shaking; weak; cough; shortness of breath; very ill/ sick; horrible chills; I had a 103 degree fever for 4 days, horrible chills that were just debilitating; ached everywhere/ severe aches; site soreness; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899) via an unspecified route of administration at left upper arm on 18Dec2020 at single dose for COVID-19 immunization. Medical history included auto immune problems, diabetes, thyroid condition, all ongoing since age 28; pemphigusvulgarism since Sep2020 and ongoing. No concomitant medications. Patient is a frontline worker. She received the vaccine on 18Dec2020 at (Name) where she works. 9 days later she got very ill. she didn't know if it's unrelated. She wanted to know if there is anything she need to be watching out for in order to get her second vaccine on Friday. She was so sick and she did have some autoimmune problems. She was really healthy. On 26Dec2020, she had a 103 degree fever for 4 days, horrible chills that were just debilitating. She was just shaking. She ached everywhere, she had severe aches since 26Dec2020. She got tested for Covid and it was negative on 28Dec2020, she had no cough and no vomit. She stayed in bed and drank lots of fluids and toughed it out. By New Year's Day (reported as 30Dec2020) her fever broke but she was so weak and didn't work. She was back at work now. Also, she experienced site soreness from the injection since 19Dec2020. She did have a cough or any shortness of breath. She felt awful. She had recovered. She was just a little nervous because everything she read said the reaction was more severe with second injection. She planned on getting the second shot. She would have a repeat Covid test on 07Jan2020. Reporter seriousness for fever 103: Medically significant. Reporter seriousness for severe aches: Medically significant. Reporter considered the causality of the event site soreness was related with bnt162b2, of the events fever 103 and severe aches was unknown. The outcome of the event fever was recovered on 30Dec2020, of event ache was recovered on 31Dec2020, of event chills was recovering, of event vaccination site pain was recovered on an unspecified date in Dec2020, of events cough and shortness of breath was recovered on an unspecified date.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the fever, pain and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

20 mins later numbness in face a head. Blood vessel popped in right eye. Dizziness feeling out of sorts. Feels like flu shot.

About 10:30 pm, 1/11/21, became very cold teeth chattering headache, sharp pains in muscles then aches, uncomfortable to touch skin. Took 2 acetaminophen, lots of blankets, able to sleep. No fever, woke up with same symptoms but milder.

Immediate numbness/tingling in left arm and left hand and both feet. Left arm/hand symptoms lasted ~15 minutes. Symptoms in both feet lasted 5-6 hours and continue intermittently.

Nausea; Diarrhea; Jitteriness; foggy head or brain; she can't concentrate /she didn't pay it any attention; sleeping a lot; sick; Headache; body aches; This is a spontaneous report from a contactable nurse. A 62-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK5730), via an unspecified route of administration on 05Jan2021 08:15 at single dose for COVID-19 immunisation. Anatomical location of administration of vaccine was right deltoid. Medical history was not reported. The patient previously took omeprazole (PRILOSEC) and experienced drug hypersensitivity and lip swelling. Concomitant medication included atorvastatin (LIPITOR). The patient experienced headache on Jan2021, body aches on Jan2021, nausea on 06Jan2021, diarrhea on Jan2021, jitteriness on Jan2021, foggy head or brain on Jan2021, sleeping a lot on Jan2021, sick on Jan2021, she can't concentrate /she didn't pay it any attention on Jan2021. The outcome of headache and she can't concentrate /she didn't pay it any attention was recovering, of pain, jitteriness, foggy head or brain was not recovered, of sleeping a lot and sick was unknown. Nausea, and diarrhea recovered on 07Jan2021.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events headache, pain, nausea, diarrhea, feeling jittery, feeling abnormal, disturbance in attention and hypersomnia cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.

became hot and dizzy and stated she had some facial pain. further assessment determined the response to be a vasovagal response.

pateint received vaccine and about 15 minutes later felt a heaviness in her arm and some pins and needles sensation in hand, arm and left leg. NO rash, no itching, no notable other side effects; denies palipations, shortness of breath, no pain , no hives, no cough or swelling

some congestion that just came on; her arm was really aching after the injection; she started coughing; voice was hoarse; light wheeze; soles of her feet were hurting; pressure in bilateral groin; aching all over; very tired; balance issues; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231) intramuscularly in left upper arm on 05Jan2021 at single dose for covid-19 immunisation. The patient got her Covid vaccine yesterday (05Jan2021) around 11 or 11:30 am in her left upper arm. She had bilateral breast cancer and had lymph nodes removed in each arm but more removed from her Right, so she got the vaccine in the left arm. She also had some skin cancers removed, one would not heal properly on her left arm and formed a blister, and her dermatologist popped it and put a band aid on it. The vaccine was given 3 inches above it. The patient's concomitant medications were not reported. The patient experienced pressure in bilateral groin, aching all over, very tired and balance issues on 05Jan2021; light wheeze on 06Jan2021. Seriousness for these events was medically significant. The patient stated she had some congestion that just came on. She felt fine yesterday (05Jan2021) right after getting the vaccine, that at work she did notice that there was something different feeling in the left side of her groin. She was not in direct patient care. She noticed on her left side in the groin, something felt different, then yesterday evening (05Jan2021) after work she was really tired in the evening, aching all over last night, even the soles of her feet were hurting, woke up like her balance was off, she would walk one way and go another, states it is not like an orthostatic issue, that she knows what that feels like. She stated that in her inguinal area she could feel pressure, bilaterally. Her arm was really aching after the injection. Her breathing, heard a light wheezing, was clearing her voice, and then she started coughing, voice was hoarse. The outcome of events pressure in bilateral groin, very tired and light wheeze was not recovered; of events aching all over and balance issues was recovering; of other events was unknown.; Sender's Comments: The reported events bilateral groin, aching all over, very tired, balance issues and light wheeze were possibly related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.

some memory loss; locked jaw/unable to open mouth; her arm hurt; pain went in her jaws; she was really scared; Excruciating pain on left ear; swelling in arm; This is a spontaneous report from a contactable other healthcare professional. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: ES1685, Expiry date: 01Mar2021) via intramuscular (left deltoid) on 28Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. She stated she is very healthy and don't have any medical conditions. She further stated that it was a scary moment, she don't want to take any chances, she was really frightened (28Dec2020). She made a complaint to let know her experience with the vaccine. Her cousin took the vaccine and told her she needed to report these events. The patient stated she experienced side effects after the first dose of the vaccine: Excruciating pain on left ear, locked jaw, her left upper arm was hurting on 28Dec2020. The pain went in her jaws and she was unable to open her mouth on 28Dec2020. She took 2 Benadryl and it relieved her. She saw on television if you experienced any side effects to take Benadryl. She also took Tylenol for the pain. She also had swelling in arm on an unspecified date in Dec2020. She also experienced some memory loss described as short-term memory loss on 30Dec2020. She stayed in bed after the vaccine, she was really scared, and stated she had memory loss and she don't have any memory problems. She was unable to remember if her car was black. She was looking for a white car. She drives a black car. She stayed in bed all day on Tuesday. Patient was asking what will happen if she does not take the second vaccine. The same morning while she was waiting to get the vaccine, a co-worker sent her a video of a woman who had received a COVID vaccine. She does not know which one. The woman experienced Bell's Palsy. The woman was crying and her face was turning side ways. She stated some people were talking negatively about the vaccine. She stated doesn't want her face to be deformed. She stated what are the cons of not taking the second vaccine. Reporter assessed the events as non-serious. Outcome of the events some memory loss and locked jaw/unable to open mouth was recovered on 30Dec2020, outcome of the events excruciating pain on her left ear, pain went in her jaws, her arm was hurt was recovering. Outcome of swelling in arm and she was really scared was unknown.

1st 24 hrs just arm soreness, 2nd 24 hrs itching and fatigue, 48 hrs, anaphylaxis, hives, rash, itching, lymph swelling, chills

No adverse effects from vaccination seen on 1/2/21. On 1/6/21 resident was seen by Dr and her baclofen pump was refilled with 20 ml Baclofen 4,000mcg/ml. ITB Rate increased by 6% to 455.5 mcg/day simple continuous rate over 3 days. On 1/8/21 at 0615 resident was shaking, lower extremities mottled, Sa02 70%, pulse 45. Oxygen started at 2 L/m per NC. At 0715 her primary physician was notified as well as her daughter. Oxygen increased to 4 L/min, sats at 83%. SOA noted, reported all over pain. At 0850 when they attempted to reposition the resident, she was not responsive. Licensed nurse assessed her and no heartbeat heard or pulse found.

0944 C/O NAUSEA, WARM SENSATION (OVERALL), TACHYCARDIA, LIGHTHEADEDNESS, SL. SHORTNESS OF BREATH. EMS ON SITE. VS: 168/71, p: 58; 97% O2 SAT R.A.; 0954: BP: 168/71, P: 58, 98% 02 SAT R.A. 1015: LEFT AND WENT TO HOSPITAL. ALERT, ORIENTED

Got first dose around 3pm Jan 12. Foot cramp around 10:30pm. Took magnesium. On Jan 13, Brief dizzy spell 7am (a few seconds); minute long dizzy spell around 3pm, another around 3:15, then a 2-hour long dizzy spell beginning around 3:30pm. Queasy till 9 pm, but no vomiting. Foot cramp again, so I got up and drank more water and took magnesium. Felt steadier.

Knot in arm, very sore arm, severe headache, fatigue, chills, fever, nauseous all on first night after shot. All gone by next morning with the exception of the headache, which is not as severe now.

Sore arm; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL0140, expiration date unspecified), intramuscular on 28Dec2020 at single dose at left arm for COVID-19 immunization. Medical history included depression and anxiety. The patient was not pregnant and had no known allergies. The patient had no allergies to medications, food or other products. Concomitant medications were not reported. On 29Dec2020, the patient experienced sore arm. The patient did not received therapy for the event. The most recent COVID-19 vaccine was administered at the hospital. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Outcome of event was recovered on an unspecified date.

WARM FEELING IN CHEST AND THROAT DENIES ANY DIFFICULY SWALLOWING. HAPPENED 5 MINUTES AFTER INJECT. BP RANGING 140/60, O2 100. OBSERVED FOR 25 MINUTES. SYMPTONS REMAINS THE SAME SENT TO ER FOR FURTHER OBSERVATION.

was afraid; she was nervous; vomiting; Fatigue; felt chills/chill became a bone chill, and she was freezing; felt chills/chill became a bone chill, and she was freezing; randomly felt miserable/she felt like her body was purging/feeling "blah"; she wasn't really eating; Feeling sick; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EK5730), via an unspecified route of administration in her right upper arm on 22Dec2020 16:00 at single dose for COVID-19 immunization. Vaccination Facility Type is hospital and which was not a facility. Medical history included type 2 diabetes mellitus from an unknown date and unknown if ongoing and it was maybe 10 years ago that she was diagnosed, and she was treated for her diabetes. There were no concomitant medications. There was no history of all previous immunization with the Pfizer vaccine (within 4 weeks) or additional vaccines administered on Same Date of the Pfizer Suspect. The patient received the first dose of the COVID-19 vaccine 22Dec2020 and is due for her second dose this upcoming Tuesday, 12Jan2021. She asked if it would be safe to receive the second dose at a different time, due to personal plans. She said after she received the first dose of the COVID-19 Vaccine on 22Dec2020, she was feeling sick in Dec2020. She said she had vomiting, chills, and randomly felt miserable, fatigue from 23Dec2020. She said she was nervous about getting the second dose of the COVID-19 Vaccine on Tuesday, 12Jan2021. She said she had plans around that time period and she was afraid she was going to be sick after she receives the second COVID-19 Vaccine dose. She asked if the second COVID-19 Vaccine dose had to be administered in the timeframe that was scheduled. The patient reported she felt chilled when she woke up the next morning, 23Dec2020. She said at first she thought she felt chilled because it was cold outside. She said after she arrived at work on 23Dec2020, the chill became a bone chill, and she was freezing. She said she realized the chill was not a normal cold feeling. She said by mid-morning on 23Dec2020, she began to vomit, and went home and went to bed. She said she got sick 2 more times that day. She said she went to work on Thursday, 24Dec2020, and randomly got sick. She said she wasn't really eating at that point (Dec2020), so it was not like she got sick before or after she ate something. She said she continued to get randomly sick through holiday, 25Dec2020. She said she felt like her body was purging. She said she was feeling "blah", but she was not bedridden or out of commission. She said she had no fever that she knew of. She said her symptoms resolved right after holiday, clarifying she started to feel like herself, saying she felt good. The patient declined any treatment and reported she didn't think her symptoms were that severe, though her family wanted her to go to the doctor. There was nothing had changed in her routine prior to receiving the first dose of the COVID-19 Vaccine. Reported she had blood work every 4 months, and her last blood work was probably done in Oct2020 or Nov2020. The events did not require a visit to emergency room or physician office. The outcome of the event feeling sick, she wasn't really eating, were resolved in Dec2020, outcome of fatigue, felt chills/chill became a bone chill, and she was freezing were resolved on 23Dec2020, outcome of vomiting, randomly felt miserable/she felt like her body was purging/feeling "blah" were resolved on 25Dec2020, outcome of fear and nervous were unknown.

Advised received first covid vaccine 12/21/2020 w/o issues. Received 2nd Pfizer vaccine on 1/11/21. Within minutes her tongue was tingling with sensation of feeling full-felt funny. 30 min later had frontal/jaw headache. 60 min later chills with goose bumps all over while working (works as resp technician at NMCP). While walking to car, her upper arm and front of thighs hurt as if exercised too much. Self treated with Advil and tylenol. --- Next day 1/12 0100am awoke with severe bilateral shoulder joint pain extending to shoulder blades, stabbing abdominal/stomach pain, nausea, urge to vomit. she returned to sleep but awoke 6am with nausea and severe diarrhea and fatigue. She c/o nasal congetion, sinus fullness and severe post nasal drip x 24 hours. S/s persisted and left work early now with severe bilateral ankle pain. She was off Wed/Thursday. Wed 1/13 her shoulder pains eased but now with severe back pain. Wed evening noted tongue swelling sensation again (has pictures) and took oral benadryl and ice chips. She went to sleep. Thursday 1/14 bilateral knee pain/joint with increased nausea again - treated with zofran. Friday 1/15 returned to work, pain in knees made gait wobbly = treated with advil. Notified ID MD and director on tongue swelling and constantly trying to clear throat = sent to ER where treated with oral decadron and M Toradol for pain. She was sent home with prednisone dose pack and compazine. Recommended f/u with HCP for further testing to r/o possibility of a mast cell disorder of familial hypertrytassemia due to her history of multiple allergies/insect allergies--

Reported left arm injection site pain, dull headache, chills and a rapid hear rate. Went to ED due to heart rate.

She said she received her First Covid vaccine on 12/22/2020. She said on 1/4/2021 she worked that evening and started having severe pain in calf of her left leg no redness ,no heat, just hurt to work 1/8/2021 She had surgery on her left leg. 2nd Covid Vaccine received on 1/12/2021 She said she had PT on her right leg with severe pain in her left calf She said she did not have any therapy on her left leg. Two ? three hours later she developed chills, temp 100.1 took temp again later is was 99. She had ultrasound that showed a large blood clot She said the PA told her the blood clot could be from receiving the Covid vaccine

Jan 12, 11:30am - Dizziness, headache, muscle aches, weakness, cold feeling, flushed. Temperature = 102.4 F. Had to leave work. Slept for 18 hours, Symptoms continued for 48 hours.

Left sided facial numbness mildly affecting left lip, cheek and area around left eye. Lasted less than an hour. Continued symptoms 48 hours after vaccine are moderate persistent headache, moderate fatigue. Feeling of not well. taking tylenol.

chills, fever over 102, terrible headache, body aches, sore arm, loss of appetite, nausea, severe fatigue, congestion

Feel like , I have a cold or allergies, Lower back pain, Abdominal Pain One Knee was shaking right after vaccine Full body pain daily mostly in the lower back

I had my first vaccination on 1/11/21 at HD. The reaction was typical- significantly sore red inflammed arm over deltoid muscle that resolved after 3 days. Second dose given 21 days later- some swelling and soreness, low grade fever. Then 3 days later, I awoke, turned in bed and experienced an intense shearing pain in my neck and arm. The pain was the worst ever felt, and was not improved with NSAIDS, Acetaminophen, Hydrocodone, or Tramadol. I went to an urgent care center on 1/16 where a tentative diagnosis of sprained neck was made. The sypmptoms continue with slight improvement with steroids, and a muscle relaxant. I am concerned because I understand that covid itself can impact the nervous system considerably. I am awaiting improvement in symptoms and if none seen then I will see my primary care MD

I started running a low grade temp about 9 pm on 1/6/2021. Woke in a.m. (early) with 100.9 temp and swollen lymph nodes under my arm and along the side of my breast and a tingly right hand. Fever broke early am on friday (1/8/2021). I was very fatigued and tired and still had a very tingly hand on 8th. Tingly slowly got better and I didn't notice it anymore on Wednesday ,13th. Fatigue was better by Sunday the 1/9th. I felt pretty much back to normal by 11th except for my hand. No treatment.

Left arm sore 2 days, 3rd day left neck, shoulder, arm , shoulder blade pain. Symptoms have not resolved 1/18/2021, not as painful now advil and massage therapist therapist treatment

Pfizer-BioNTech COVID-19 Vaccine EUA: soreness in left arm at shot injection site started around 8:00pm (shot was at 215pm). Upon awakening 1/19 at 6:00am, arm continued to be sore and I had fever registering at 102.5. I took two Tylenol then and again at 3:00pm. Headache appeared around 9:00am and was gone by 7:00pm. Temp began to decrease at 10am, to 101.1 and was 99.3 at 2:30pm. Sunday morning woke up with no soreness in arm or fever/headache.

Once i received the 2nd dose- My arm swollen for 3 days - continue to be red as thought rash going over the top half of arm around the injected area. chills , body aches, fever. stayed in bed the next 3 days. 4 day sweating, and low grade fever , fatigue very weak.

Reported PM post vaccine she had fever, malaise, headache, left axilla swelling, "pleurisy" feeling in chest. No sob. Early on 1/8/21 in the AM, had 2 runs afib, that responded to metoprolol. She reported the afib to her cardiologists. Called again on 1/19/21 to report continued fevers, fatigue, body aches, nausea, and chills that caused her to call off on 1/17/21. Ordered COVID-19 PCR.

"pains in my stomach on the left side from under my breast to my umbilicus. they are not intestinal, but more superficial. It is a general soreness with periodic stabbing pains." --still continuing after 5 days post vaccination

rosacea flare up; facial flushing; This is a spontaneous report from a contactable consumer (reported for himself). A 62-year-old female patient (not pregnant) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1658), via an unspecified route of administration on 06Jan2021 12:15 at single dose at left arm for COVID-19 immunization. Medical history included asthma; osteoporosis; dry eye; Known allergies: Omnipaque CT injection fluid; environmental allergies including pollen and dust mites; rosacea he had many years ago including facial redness and burning. Concomitant medication included fluticasone propionate (FLOVENT). The patient previously took denosumab (PROLIA) injection last taken on 06Aug2020. Facility type vaccine was Hospital. No other vaccine in four weeks. About eight hours after the injection the patient started having facial flushing and was advised to go to an emergency room. Patient saw Dr. (Name) at (Institution name) who prescribed Benadryl, Prednisone and Pepcid and the facial flushing subsided but came back the next day. The patient had been experiencing a recurrence of symptoms due to a rosacea flare up that he had many years ago including facial redness and burning. Adverse events start date on 06Jan2021 20:00 and resulted in Emergency room/department or urgent care. The patient didn't have COVID prior vaccination and didn't have COVID tested post vaccination. The outcome of the events was recovered with lasting effects.

tongue itching; lips itching; face feels flushed; left hand is tingling or numb (the palm)/left hand that's puffy and tingling; left hand is tingling or numb (the palm)/left hand that's puffy and tingling; left hand is tingling or numb (the palm)/left hand that's puffy and tingling; palm of left hand was itchy; inside of nose; it feels like someone is pinching nose/It's swelling; inside of nose; it feels like someone is pinching nose/It's swelling; face has a rashly feeling; This is a spontaneous report from a contactable consumer reported for self. This 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via unspecified route of administration on an unspecified date at single dose in left arm for COVID-19 immunisation. The patient medical history and concomitant mediations not provided. The patient reported that she had the vaccine at her work, waited 15 minutes and left the clinic. About 20 minutes then, her tongue was itching, lips were itching; face felt flushed. Face had a rashly feeling. Her left hand was tingling or numb (the palm). Her palm of left hand was tingling and itchy. The inside of nose; it feels like someone is pinching nose. It was swelling. The patient stated "Whenever I get stung by bees, this is how I feel". The patient stated that it was mild. She stated she was having a reaction, but not severe enough maybe it will subside. Her left arm is where she got the injection and it was left hand that was puffy and tingling. The patient stated that she also had N95 mask on and she guess she get that reaction from it. The patient stated that she was just wondering what she should do, if she should just go by some diphenhydramine hydrochloride (BENADRYL). The outcome of events was not reported. Information about lot/batch number has been requested.

A little over 12 hours after receiving my 2nd dose at 8:42 am, I woke up at approximately 11:15 pm to find that my tongue and throat were swelling. I immediately took 1 25mg benadryl and went to the Emergency Room (ER). After many questions and examination of my mouth. I was given another benadryl, prednisone, and famotidine. I waited and was observed for approximately 2.5 hours in the ER. At that time it was obvious that the medication was effective and I was comfortable leaving the ER to return home. I had prescriptions for more prednisone and famotidine to take for 5 days. On Wednesday, I felt well enough to go to work at my school, though I did light duty. On Thursday, I was also at school and also attended a physical therapy session and exercise class. I talked at length with my PT about my experience and she could tell that I was feeling good (presumably from the prednisone) and cautioned me about not overdoing things during exercise. I felt like my tongue was beginning to swell and the PT mentioned that my words sounded a bit funny (she was the only one to comment on this). I then went to dinner at my daughters house and began to feel tired from the benadryl. Upon arriving home and getting ready for bed, my husband and I both noticed how flushed my chest and face had become during the day. My throat and tongue were still somewhat swollen and my throat was beginning to hurt. During the day on Thursday, I had registered with the local Covid information website and had received an email stating that I should feel free to call the triage phone number if I needed. At approximately 9:45 pm I called and talked with a nurse who urged me to return to the ER because of the flushing and continued swelling. In the ER I was seen by a different doctor who was concerned not so much about the swelling, but about the white streaks in my throat and had me swabbed for strep throat. That test was negative. He said he had read my chart from Tuesday night and felt that the medication that had been prescribed was appropriate and that he didn't feel anything needed to be changed. He asked about how bad my throat felt and wrote a prescription for Magic Mouthwash and I asked for an EpiPen, which he also prescribed. We arrived home at approximately 12:00 am, but it was still difficult to lie down and sleep. I had already decided that I would not go to school on Friday and stay home and rest. I needed to pick up my prescriptions when the pharmacy opened and I ran a few other errands while I was out, but returned home and slept most of the afternoon. I have not been very energetic this evening, but decided that I wanted to get this form filled out. At approximately 10:00 PM on Friday evening, I hope that I am able to sleep better than I have the last several nights.

1/14 am. General malaise and fever shortn of breath, cough sneezing body?s aches joint pain ongoing for last 10 days Still low grade fever 99.8 and cough headache body aches weakness fatigue short of breath

Brain fog; headache; Muscle spasm at injection site; Severe fatigue; joint pain; Driving difficult; Swelling; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date not reported), via an unspecified route of administration in the left arm on 08Jan2021 16:00 at single dose for COVID-19 immunisation. Medical history included latex allergy. Concomitant medications included ibuprofen and paracetamol (TYLENOL). The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient previously took first dose of bnt162b2 (lot number: Ek5730, expiry date not reported) in the right arm on 18Dec2020 15:00 at single dose for COVID-19 immunisation. On 08Jan2021 at 18:00, the patient experienced brain fog, headache, muscle spasm at injection site, severe fatigue, joint pain, driving difficult and swelling. It was unknown if treatment was received for the adverse events. Clinical outcome of the events was not recovered.

Nearing 24 hours after receiving my second vaccine, I began to feel ill, similar to an intestinal flu coming on, weak and dizzy. I felt that way for approximately 20 minutes and went lie down but began to feel more dizzy and then very nauseated. I then vomited several times and afterward began to feel steadily better. The whole even was approximately 2 hour before I felt back to normal.

Unable to get out of bed: She is so sleepy and has no energy; Wiped out of energy; lots of flatulence; Chills; Joint pain; Lower GI symptoms; she is also feeling cold; This is a spontaneous report from a contactable nurse (patient). A 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT#: GL3248 (Caller said that the G may be an E.)), via an unspecified route of administration in the left arm on 07Jan2021 at second single dose for working with cancer patients. Medical history included ongoing diabetic and ongoing hyperthyroidism, both diagnosed about 6 years ago and were under control. There were no concomitant medications. Historical vaccine included BNT162B2 on 18Dec2020 for working with cancer patients (First dose, lot number: EJ1685, injection in the left arm). On 11Jan2021 the patient had chills, joint pain, and lower GI symptoms. Her lower GI symptoms included diarrhea. Then caller clarified that it was not diarrhea but the urge to go. The stools were solid. She also had lots of flatulence. She was also wiped out of energy, around like 2 PM on 11Jan2021 she went up a flight of stairs and was so exhausted. The patient is a nurse. She was in her office that day and had to literally lay on the floor because she was so wiped out of energy. She left work early and went to bed. Then the next day 12Jan2021, she was unable to get out of bed the whole day. She is so sleepy and has no energy. She went to bed last night at 08:30, but is still so sleepy. Today she is feeling better, but still had lower GI symptoms. She was also feeling cold, which she normally is always hot. She was having to put 5 blankets on her. Outcome of the event chills was recovered on 12Jan2021, of events joint pain, lower GI symptoms, wiped out of energy, unable to get out of bed was recovering, of events flatulence and feeling cold was unknown. The reporter considered the event chills, joint pain, lower GI symptoms, wiped out of energy, unable to get out of bed as serious (disability) and related to BNT162B2.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported chills, joint pain, lower GI symptoms, wiped out of energy, unable to get out of bed and the administration of the COVID 19 vaccine, BNT162B2, given the plausible temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.

arm soreness, joint pain, chills, fatigue x 48 hours headache start at same time but has gotten worse on day 3 post vaccine and not relieved by acetaminophen

joint pain; bad back spasms in the middle of the back radiating up through right should to right arm; Sweating; arm pain; she couldn't do anything with her right hand. She "couldn't open a soda can, the next morning couldn't get socks on, hand wouldn't work, and had a difficult time writing or typing".; arm shoulder blade rib cage are sore; arm shoulder blade rib cage are sore; This is a spontaneous report from a contactable consumer (patient, healthcare tech in the ER). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on Jan2021 at single dose for COVID-19 immunization. Medical history included spondylosis. Concomitant medications were not reported. patient calls today to report symptoms following administration of the covid vaccine. Caller reports that she got the vaccine on Friday. Reports that on Saturday she started to have joint pain everywhere on Sunday she felt a little better. Reports that on Monday she got up and had really bad back spasms in the middle of the back radiating up through right should to right arm. She went to work, only worked for 2 hours and then checked into the ED. They did an EKG because she was sweating and was with arm pain. They did X-rays and gave her steroids and gave her a pain shot stating it didn't do anything, states they put her on steroids to come home with, muscle relaxers to stop spams. Reports that on Monday night she couldn't do anything with her right hand. She couldn't open a soda can, the next morning couldn't get socks on, hand wouldn't work, and had a difficult time writing or typing. The spasms won't stop, everything; arm shoulder blade rib cage was sore. Went back to the ER on Tuesday, they did a thoracic and cervical MRI, nothing looked different or wrong. they told her to stay on steroids and keep taking muscle relaxers, with ibuprofen and Tylenol. She also asks, what should her do, and if her history of spondylosis triggering this reaction. Patient was recovering from joint pain, was not recovered from bad back spasms in the middle of the back radiating up through right should to right arm and arm shoulder blade rib cage are sore. Outcome of the events was unknown. Identification of the case safety report serious was No. Information on the Lot/Batch number has been requested.

Client approached a Public Health Nurse after 30 minutes of waiting and stated her hands felt itchy, prickly, and were reddened. Denied SOB and denied chest pain. Benadryl was offered and taken, client felt better after that and was released, offered a ride home, but left with a friend.

started last week feeling numbness in my right foot. Then went to my right leg and up to my right arm and hand . Then went to the left arm. Starting to have pain in my right hand and leg. The numbness grew daily. When i stand the numbness goes away and then when i lay down or sit down it comes back.

Had 2nd shot on Tuesday 1/19 at 1500. Went to bed felt a little nausea, woke at 0300 1/20 with runs. Finally back to bed to continue with violent shakes. fever, aches and head aches lasting until late Thursday afternoon. Exhausted feeling still remaining through Saturday. Felt myself on Sunday 1/24

The next day after the vaccine my arm was red and really painful. Each day the redness got larger and by friday it was near my elbow so I went to an Urgent Care. I was given a prescription for an antibiotic because they states infection had set in it and I also took tylenol and antihistimines to help with the pain.

Woke up at 5am 1/26/21 with Headache, body aches, ax temp 100.4. Left arm pain with enlarged lymph nodes left axillary area. Fatigued. Headache became debilitating around noon. Extra strength Tylenol decreased temperature and body aches but did not help with headache. Fatigued all day. 1/27/21 10amFatigued, headache, body aches gone.

Vaccine given high up on shoulder, not 3 finger widths down. Persistent pain right shoulder and upper arm, positional discomfort. Pocket of fluid accumulation above right clavicle.

approx. 15-20 min after vaccine admin, pt c/o "ha, fatigue", evaluation by EMT, vs 158/86 100, spo2 97, p=101, pt reports that this bp is "normal for her", she remained alert aned oriented, progressed to feeling "flushed from head to waist", at 5:05 pm, pt feels that these s/s r/t "very busy all day,this is the first time I have sat down all day", bp 168/95, 103, spo2 96, cool pack applied to back of neck, pt reports increase in feeling , "flushed", 1720- pt c/o "my neck feels swollen, my jaw hurts", denies shortness of breath, or chest pain, no hives observed on head, or abd, pt agrees to more advanced eval at ER, husband notified, 1730, pt experiences dry heaves, no emesis, bp 179/109, Ambulance called to transport to ER, IV initiated by EMT, 1740, pt to stretcher, with ambulance crew, report given, pt continues to deny shortness of breath, and chest pain, she remains alert and oriented.

approximately 10 minutes after receiving vaccine patient complained of fullness in throat and difficulty swallowing, also felt tremulous and like heart was racing, some visible swelling of lower lip, initial vitals revealed pulse ox of 99, bp 151/70 and hr of 107, lungs clear without wheezing, no urticaria, given 25mg po Benadryl with gradual resolution of symptoms and normalization of vital signs

migraines; arm is sore where the injection; she could hear like blood going through her, and if she moved it got faster and faster; Chills; muscle aches; not feeling well; Headache; fever; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received bnt162b2 (BNT162B2, manufacture: Pfizer), via an unspecified route of administration on 21Dec2020 by injection once to right arm (Lot Number: EJ1685) at SINGLE DOSE, via an unspecified route of administration on 11Jan2021 (Lot Number: EL3302) at SINGLE DOSE for covid-19 immunization (reported as healthcare worker, medical receptionist). Medical history included Other Conditions No. There were no concomitant medications. The patient experienced fever on 11Jan2021, headache on 12Jan2021, chills on 12Jan2021 23:30 , muscle aches on 12Jan2021 06:00, not feeling well on 12Jan2021 , migraines and arm is sore where the injection on an unspecified date. The caller had her second vaccine (later clarified as COVID vaccine) on 11Jan2021, and had the same symptoms as on the first one. They were not as bad, and she thought the first one was pretty bad. She previously reported her symptoms with the first vaccine. Symptoms with the second were fever, headache, chills, of course, and muscle aches, her arm weighs a ton, and not feeling well. Fever was noted when she was sleeping, it is now 99.6, but it was was 103. Headache was noted in the early morning, it was not a normal headache, it was the worst thing, and she is prone to migraines, but this was not even like that, she could hear like blood going through her, and if she moved it got faster and faster, one time, she stood still and it was like ahhh! Chills started about 11:30 last night, they went away this morning, about 11AM. Muscle aches started at 6AM yesterday, and are finally gone, as of probably about 9AM, they are fine now, just her arm is sore where the injection was. Not feeling well started yesterday and is getting better. First dose was 21Dec2020, she previously provided lot EJ1685, confirms both were Pfizer vaccines. The outcome of the event fever, not feeling well was recovering, headache recovered on 13Jan2021, chills recovered on 13Jan2021 11:00, muscle aches recovered on 13Jan2021 09:00. No follow-up attempts possible. No further information expected.

(Friday)Immediately after the injection-dizziness, vertigo, tunnel vision, blurred vision, pin point pupils, unable to talk, headache, facial and lip numbness, numbness traveled down the right side of my body (side of injection) trembles, weak legs, very weak all over. EMTs were called but I didn't go to the hospital. My son picked me up and took me home because I was unable to drive. On the way I experienced loss of vision and speech for about 5 minutes. When I got home, my legs were so shaky that I had to have help walking. I started getting severe chills that took 3 hours to get warm (2 heavy blankets, space heater, and heating pad). I was very fatigued and felt bad the rest of the day. (Saturday)The next day I had flu-like symptoms; headache, joint aches, chills, nausea, extreme fatigue. Sunday was better but still had to rest most of the day because when I would stay up for over 30 minutes, the symptoms would return. Monday- stomach cramps, headache, fatigue but went to work (30 minutes late due to stomach) and left 30 minutes early.

The vaccine was administered in my left arm, but my right hand started feeling numb. It only lasted about 30 mins and I was able to drive home, but it was very weird and unexpected.

she was injected, sh stopped eating and talking, the doctor watched her for 2 days. had her transported to the hospital. i was told she had tested positive for COVID 2 times once at the home and once at the hospital. with in 2 DAYS at the hospital she wa on a ventilator 2 days later she died. i talked with the rehab center and confirmed she tested negative for COVID on Dec 27th 2020 and was given the Vaccine on the 29th Dec 202 was in the hospital 4 day later, was on a ventilator 4 days after that then died a few day later as her heart stopped beating. all the while i had POA and was not contacted by Hospital staff until after they had made the next step.

racing pounding heart rate 110-126 (normal is 60); racing pounding heart rate 110-126 (normal is 60); Very weak; chills; whole body achiness; This is a spontaneous report from a non-contactable nurse (patient). A 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK4176) via an unspecified route of administration on the left arm on 18Jan2021 11:00 at a single dose for COVID-19 immunization. Medical history included coronavirus and allergies: sensitive to milk protein and gluten sensitivity. Concomitant medication included St John's Wort, colecalciferol (VITAMIN D [COLECALCIFEROL]), calcium carbonate (TUMS [CALCIUM CARBONATE]) and multivitamin. The patient previously took casein and experienced allergies. On 19Jan2021 05:00 AM, the patient experienced racing pounding heart rate 110-126 (normal is 60), very weak, chills, whole body achiness. Work the night shift, 11p-7a and symptoms started around 5am. No treatment was received for the events. Patient was not pregnant. The facility where the vaccine was administered was in a Nursing Home/Senior Living Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Post vaccination, the patient has not been tested for COVID-19. Outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

Patient had some flushing, sweating and headache. Patient also had generalized itching over entire body. no rash noted.

101.5 fever for approx. 30 hours; severe headache with light sensitivity for days 1-5; severe headache with light sensitivity for days 1-5; muscle cramps; joint pain; nausea; extreme fatigue lasting several days.; This is a spontaneous report from a contactable Other Health Professional (HCP) (patient). A 62-year-old female patient (pregnant: No) received the second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Lot number: EL0140), via unspecified route of administration on left arm on 12Jan2021 at 10:00 AM at single dose for covid-19 immunisation. The relevant medical history included Rheumatoid Arthritis, Asthma, Hypertension, Multiple allergies, Peripheral Neuropathy, degenerative disc disease, known allergies: Sulfa drugs; Tetracycline; Nsaids; Aspirin; Ioxinol; multiple pollens & molds; capsicum, peppers, black tea, black cohosh, and more. Concomitant medications included valsartan (DIOVAN), adalimumab (HUMIRA), leflunomide, hydroxychloroquine phosphate (PLAQUENIL), montelukast sodium (SINGULAIR) and levocetirizine dihydrochloride (XYZAL). The patient previously received first dose of BNT162B2 at the age of 61 years old on 22Dec2020 (first dose, Lot number: EL1283, 03:00 PM, Left arm) for covid-19 immunisation. The patient experienced 101.5 fever for approx. 30 hours; severe headache with light sensitivity for days 1-5; muscle cramps, joint pain, nausea, and extreme fatigue lasting several days on 12Jan2021 at 04:00 PM. No treatment received for the events. No covid prior vaccination and no covid tested post vaccination. The outcome of the events was recovering.

Dizziness; nausea; headache; constant eye and nose drain; constant eye and nose drain; burning eye and nose; burning eye and nose; weakness; tiredness; sore lips and throat; sore lips and throat; sore on tongue; chest tightness; This is a spontaneous report from a contactable consumer reporting for herself. A 62-year-old female patient received the 1st dose of bnt162b2 (BNT162B2) at single dose at left arm on 14Jan2021 11:30 for Covid-19 immunisation, administered at hospital. Medical history included hypertension, high cholesterol, diabetes mellitus, allergies penicillin. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication within 2 weeks of vaccination included atenolol (manufacturer unknown), losartan (manufacturer unknown), atorvastatin (manufacturer unknown), hydrochlorothiazid (manufacturer unknown). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Jan2021 07:00 the patient experienced dizziness, nausea, headache, constant eye and nose drain, burning eye and nose, weakness, tiredness, sore lips and throat, sore on tongue, chest tightness. The patient underwent lab tests and procedures which included Sars-cov-2 nasal swab test: negative on 19Jan2021. The outcome of all events was not recovered as all ongoing now for 1 week. The events were considered non serious. Information on the lot/batch number has been requested.

chills day 1 and 2; tiredness; headache; muscle pain; joint pain; feeling unwell; dizziness; weakness; sleeplessness; sinus unable to drain, feels like sinus infection but no fever; This is a spontaneous report from a contactable health care professional (patient). A 62-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL1283) in the hospital, via intramuscular route of adminsitration on 08Jan2021 at 15:00 at a single dose on the left arm for COVID-19 immunization. Medical history included Diabetes, High blood pressure, Osteoporosis, Hyperlipidemia, GERD, Diverticulosis and allergies to soaps, shampoos and lotions all from an unknown date and unknown if ongoing. Concomitant medication included metformin (manufacturer unknown), losartan (manufacturer unknown), ezetimibe (manufacturer unknown), esomeprazole (manufacturer unknown), dulaglutide (TRULICITY) , hctz (manufacturer unknown), denosumab (PROLIA), Alive multi vitamin (as reported), vitamin d3 (manufacturer unknown), ascorbic acid, colecalciferol, copper gluconate, cyanocobalamin, durapatite, folic acid, glucosamine hydrochloride, magnesium oxide, manganese sulfate, phytomenadione, sodium borate decahydrate, zinc amino acid chelate (BONE UP), alpha-amylase swine pancreas, cellulase, lipase, protease nos (DIGESTIVE ENZYME) and curcuma longa rhizome (TURMERIC CURCUMIN [CURCUMA LONGA RHIZOME]). The patient had no other vaccines in four weeks. The patient did not have COVID-19 prior to vaccination. It was reported that the patient had chills day 1 and 2, tiredness, headache, muscle pain, joint pain, feeling unwell, dizziness, weakness, sleeplessness and sinus unable to drain, feels like sinus infection but no fever all on 08Jan2021 at 19:00. The patient took Advil, Mucinex and Walphed as treatment for the events. The outcome of the events was not recovered. The patient has not been tested for COVID-19 post vaccination.

headache; Itchy; prickly skin all over body; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiration date: unknown), via an unspecified route of administration on the right arm on 10Jan2021 at 09:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EK5730 on 20Dec2020 at 09:00 AM on the right arm for COVID-19 immunization, and Benadryl. The patient took Benadryl before the second dose and throughout the day, and it somewhat helped with the constant skin irritation. On 10Jan2021, the patient experienced headache, itchy and prickly skin all over her body. No admission to hospital involved and no treatment was received. The events resolved on an unspecified date in 2021.

Called PCP, from the note: I got my shot on Jan 19. But last Friday I have been down with a horrible flu. I'm wearing diapers because of uncontrollable diarrhea. I can't leave my sofa to walk over to my desk because I'll be so out of breath. I have a cough that produces a pink or gold Phelm I have dry mouth. I have no appetite I'm so weak and have lost 15 pounds. Don't know what to do. My next Covid is shot is feb 11 Called employer on 2/3/21 but hung up. Tried calling multiple times to follow up. In triage she stated she had a COVID test scheduled and had spoken with her PCP. COVID test through PCP: 2/4/21 She passed away the night of 2/4/21

Came on fast and furious Horrible Chills lasting about 3 hours, threw up about 20 times, sinus headache for a couple of days, low grade fever for about 12 hours , achy all over felt like pin pricks up and down my body to the bottoms of my feet. At one point my air passage felt blocked possibly by something that I threw up.. had trouble regaining my breath. I was surprised at how fast and furious this came on.

I had difficulty forming thoughts and speaking in more than a few words at a time. I was aware I was trying to think or respond, but felt somehow blocked from access and ability to think and speak. This experience lasted for about 28 hours, and then my access to cognition returned. By the way, I am a doctoral level psychologist for whom these skills are typically easy.

Sore arm and mild chills 5 hours after injection. Moderate chills, fatigue, headache, sore arm 20 hrs after injection. Went to bed and slept 2 hrs, started feeling better 26-36 hours after injection. Completely recovered by 48 hrs.

Started to have weird body weakness sensation associated with mild nausea when I lay down at night. Almost every night. As soon as I lay flat. Comes in waves. Causing me having problems falling asleep. Also happens when I tried to fall back to sleep. Mostly when I am about to fall asleep. During the day I am ok if I am upright. No fever or other symptoms. Getting insomnia from it every night.

extreme weakness; increase in my spasticity; This is a spontaneous report from a contactable healthcare professional (patient herself). A 62-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 16:15 at single dose for covid-19 immunization. Medical history included MS (multiple sclerosis); kidney disease. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication included glatiramer acetate (COPAXONE) from 19Jan2021, escitalopram oxalate (LEXAPRO) and antihistamine, magnesium. The patient previously took sulfamethoxazole, trimethoprim (BACTRIM) and experienced allergies. The patient received other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced extreme weakness and an increase in her spasticity related to MS on 20Jan2021 12:00. Since the vaccination, the patient had not been tested for COVID-19. The events were reported non-serious. Outcome of events were recovering. No treatment was received for the events. Information on the lot/batch number has been requested.

slight itchy, tingly, red rash on R foot (plantar surface) and ankle. No blisters. Also some tenderness in lower calf but no rash there. No treatment d/t it being mild reaction

I was sitting in my sofa watching television and felt this odd dizziness overcome my head. I felt nauseated and hot. I closed my eyes for a few minutes and when I hope Ed the the intense dizziness subsided. I still feel a little dizzy, very tired and switch from feeling hot to very cold.

Pfizer-BioNTech COVID-19 vaccine EUA---- 2/4/21 0430am woke up with numbness in left leg which progressed to entire left side of body. 02/05/21 03:30 PM presented to ER for evaluation of left side body numbness. Numerous test & blood work performed. D/C home with diagnosis of transient cerebral ischemia & instructed to follow up with neurologist.

heart rate of 160; severe nausea; arm soreness; muscle soreness in left arm; general fatigue; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283), via an unspecified route of administration on 21Jan2021 13:00 at single dose in left arm for COVID-19 immunisation. Patient age at time of vaccination was 62 years. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK5730) administered on 30Dec2020 at 01:00PM and the patient said she did not have a reaction after the first vaccine. The patient received no concomitant medications. She stated that she had no other recent vaccinations or new medications. One thing that may be important is that she did do a 7 day detox that ended the Sunday before her second vaccine dose, so her body was pretty much having no impurities in it, and she has been eating clean since then, maybe having something foreign put into her body set it off after detox. The patient experienced arm soreness and general fatigue on 21Jan2021, and on 22Jan2021 at 01:00 she experienced severe nausea and heart rate of 160 (which was reported serious as medically significant). Patient reported that after her second dose of the COVID-19 vaccine she had a significant side effect that didn't happen until 10-12 hours after getting the vaccine. She did not have a reaction after the first vaccine. After the second injection her arm was sore, and she had general fatigue. She had the second dose injected Thursday at around 01:00PM, then at one in the morning her heart rate was 160, and she had severe nausea. She was that way until 08:00AM. Her heart rate was 120 probably by 09:00AM, then came down to 100, she has never had anything like that before. Her arm soreness was a deep muscle soreness to her left arm. The fatigue was a couple hours later after she got the second dose of the vaccine. The nausea started at 01:00AM, and lasted until six to eight, she did no treatment, and it improved and is still gone now. For her heart rate of 160, she had no treatment, though she probably should have gone to the hospital, but it came down. She usually runs a heart rate of 60-70, it went back to normal Friday, probably in the afternoon on the 22nd, about 12 hours after that started. The patient stated that she feels this is medically significant for her heart rate to be that high. She had contacted her primary care physician (PCP), but they didn't call her back for 4-5 hours, by then she was fine. She doesn't think that this was treated well by her PCP, and that they should have done an electrocardiogram (EKG) and follow up labs, she is changing her PCP as a result of this. She is concerned about the people who will be getting their second dose, she has been helping with these, they have patients that are over 100, they wouldn't survive that rapid heartbeat. The outcome of arm soreness/muscle soreness and fatigue was unknown.; Sender's Comments: The reported event of heart rate increased was likely causally related to the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.

Moderate to severe fatigue; moderate nausea; slight joint pain; Vomiting; Dose 1 administration date 21Dec2020, Dose 2 administration date 07Jan2021; severe underarm pain; moderate chills; shaking; severe migraine-like headache; This is a spontaneous report from a contactable other health professional reporting for herself. A 62-year-old female patient received the second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number: EK4176), via an unspecified route of administration on 07Jan2021 10:30 AM at single dose in Right arm for COVID-19 immunisation. Medical history included IV dye allergy and Allergy when on antibiotics from an unknown date. Concomitant medication included acetylsalicylic acid (ALKA SELTZER) received within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number: EL0140) on 21Dec2020 10:30 AM in Right arm for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced vomiting 12 hours after second injection on 07Jan2021 at 10:30 PM, then severe underarm pain and moderate chills and shaking 14 hours after, then severe migraine-like headache and slight chills 22-26 hours after. Moderate to severe fatigue, moderate nausea, slight joint pain for another 2 days, on 10Jan2021. Third day after injection was slight nausea and moderate fatigue. Fourth to sixth day after injection was slight fatigue. Since the vaccination, the patient has not been tested for COVID-19. Treatment was not received for the adverse event. The outcome of events was recovered. The case was reported as non-serious.

Hypertension; tachycardia; Feels hot; heart rate is high; This is a spontaneous report from a contactable pharmacist. A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), intramuscular in left arm on 13Jan2021 at single dose for COVID-19 immunization. The patient's medical history was not reported. The patient has no known allergies. Concomitant medication included simvastatin and acetylsalicylic acid (ASPIRIN (E.C.). The patient was not pregnant at time of vaccination. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced hypertension, tachycardia, feels hot and heart rate is high on 13Jan2021. The outcome of the events was recovering. The patient received treatment such as Amlodipine and lisinopril oral for the events.

collapse and passed out; Woke up at midnight with severe leg cramps; I turned white as a ghost and sweats; I turned white as a ghost and sweats; Got the chills after sweating; This is a spontaneous report from a contactable 62-year-old female consumer reported for herself that she received 1st dose of bnt162b2 (BNT162B2; lot number EL9261) on 26Jan2021 04:30 PM at left arm for COVID-19 immunization in Public Health Clinic. Medical history and concomitant drugs was none. The patient woke up at midnight with severe leg cramps, tried walking it out, collapse and passed out (according to husband). He stated that the patient turned white as a ghost and sweats. After coming too, drank electrolytes and water. The patient got the chills after sweating. It took a while for her to warm up and go back to sleep. Event start time was reported as 27Jan2021. The outcome of the event was resolved.

woke up not feeling good; a few hours later headache and dizzy; dizziness increased; driving and hard to keep eyes open; feeling overall sick and getting very hot; threw up quickly three times water only nothing in my stomach. Got home and went to bed and slept for a few hours. Woke up and felt better. Headache and fatique so rested the day; next day felt better with headache and rested. Third-day slight headache but felt much better.

Prior hx. of anapylaxis from ferrlicit, hives from gallalinium, sulfa drugs and clindamycin. Received Trastuzubam yesterday. Individual from pharmacy called and approved vaccine administration. At 11:37 am patient noted tingling in both arms and legs and slight light-headedness. Denied any trouble swallowing, facial or tongue swelling. states a little chest tightness but not enough to take her inhaler. Vital signs at 12:09pm BP 149/75, pulse 90, Pulse ox. 100%.At 12:20pm patient still admits to bilateral leg and arm tingling, no facial/tongue swelling or difficulty swallowing. No change in chest tightness.

Developed typical flu symptoms but developed severe incapacitating migraine/nausea/photofobia/vertigo. Felt feverish but no temp. Severity so bad almost went to ER. Took Imitrex x2 with chest tightness occurring after 2nd dose. Lasted x3 days then pressure on right side of head eye for a month. Elected not to do 2nd shot due to above s/s.

Pt. received vaccine at 1805 and Pt. came to RN stating she felt heart racing at 1828. RN took patient to sit in observation area. Asked if any trouble breathing, stated no. RN noted patient with flushed face and red sclera. Patient placed on monitor with HR in 113, oxygen saturation 97% and blood pressure 186/108. Oral benadryl given at 1832 with water. Patient continue on monitor with HR in 107, at saturation 97% and blood pressure 186/103. 911 called at 1835 due to blood pressure issue and cont. flushed. EMT arrived 1842 and took over care. Pt. EKG done by them and then taken to ER at 1900.

Woke up one morning w/pain/ache in left lower jaw/back teeth, especially w/opening my mouth. Chewing on back molars hurt. As time went on pain worsened and radiated into my cheek, left eye and left ear. ~ One week later, I saw a dentist; he couldn't say whether it was TMJ or tooth problem, so sent me home w/quick splint to separate my top & bottom teeth at night and some exercises. These didn't help, so ~ a week after that, he gave me antibiotic. No improvement in symptoms until ~ a week after that. I saw pcp, as it felt like something was crawling inside my left ear. Ears were fine; she agreed w/inconclusive answer of dentist - at this point, there was some improvement in my symptoms. She suggested prescription-strength Naproxen for 10 days, which I did. the pain/ache has been mostly gone since completing the Naproxen. For last few weeks, I've been back to normal - no ache/pain/strange sensations in ear at all.

The site got worse through Thursday and was red, hot; Weakness; woke up with 100.5 degrees temperature; Difficulty remembering things; Vomiting; Headache 10/10; developed a red area below injection site/The site got worse through Thursday and was red, hot; This is a spontaneous report from a contactable nurse. A 62-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), intramuscular in right deltoid on 24Jan2021 at a single dose for prevention (COVID-19 immunization). Medical history included Low immunoglobulin/compromised immune status/Low immunoglobulin diagnosed 8 years ago, hereditary angioedema from 2010, asthma diagnosed in her 20's, Allergic to Thermarisol, diagnosed allergies, respiratory illness, and endocrine abnormalities (including diabetes) and obesity. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (LOT number: EJ1686) in right deltoid on 03Jan2021 for covid-19 immunization, and flu shot on Sep2020 without adverse event. She got second injection on 24Jan2021. On 25Jan2021, she woke up with 100.5 degrees temperature and could not stop vomiting. She had to go to the ER. They gave her Zofran, IV and also Toradol because she had a number 10 headache. She continued with low grade temperature throughout week from 99.5-100.5 degrees Fahrenheit, and by Tuesday morning, she developed a red area below injection site. By Thursday, there was a red area growth to 13 cm x 15.5 cm on the injection site. She could not remember her email address and said her brain was not thinking. This started after the vaccine that she began having difficulty remember things. She never had a headache that bad. It improved but she has a lingering headache still. She continued to have a temperature from Monday to Saturday. Currently, she does not have an elevated temperature. Difficulty remembering things was reported as just irritating, but significant. The site got worse through Thursday and was red, hot and ended up measuring 13 cm x 15.5 cm. Regarding weakness, she could walk but medics had to help support from her seat to the ambulance. The outcome of the events red and hot injection site was not recovered; the outcome of the events vomiting, headache, weakness was recovering. The outcome of difficulty remembering things was unknown. The outcome of high temperature was recovered on an unknown date. The events was assessed as medically significant.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported events and the use of BNT162B2 cannot be excluded. The case will be assessed further upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.

I woke up with runny nose and constant sneezing, muscle aches and pains. Fever 103 and chills and uncontrollable vomiting. Suspects cerebral edema because of head ache and vomiting. Took 8 mg of dexmetholzone and Zofran. Neither were helpful. I took a shot of emetrex in case of a migraine. Vomiting has stopped but fatigue and weakness persists.

Patient received second dose of Pfizer COVID-19 vaccine today. While in recovery area, patient alerted staff to feeling of swelling in the mouth. Patient was observed sitting in the recovery area in no acute distress, speaking without difficulty, no dyspnea observed. Patient reported feeling of tingling in her mouth/tongue and tingling in the left arm. Patient reported history of reaction to nuts that caused the same sensation in mouth. Denied history of anaphylaxis. Following reaction to nuts, the patient sought care at an Urgent Care facility where they administered benadryl and a steroid. Patient stated she was very nervous to receive this vaccine. I requested for an additional RN to observe patient and assess condition. Second RN assessed patient, discussed recommendation to visit emergency department, and escorted patient to the Emergency Department for treatment.

The left side of my face, ear, throat and teeth hurt; The left side of my face, ear, throat and teeth hurt; pain in neck; pain in left shoulder; The shortness of breath lasted over; My lips were tingly; I could feel the end of my nose. My throat was closing/throat closing a little bit; I had pain in my arm; my muscles ached.; The left side of my face, ear, throat and teeth hurt; The left side of my face, ear, throat and teeth hurt; anaphylaxis; allergic reaction to the first dose of the Pfizer COVID 19 vaccine; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EN5318), via an unspecified route of administration on 22Jan2021 at 10:30 at single dose in left arm for covid-19 immunization. Medical history included drug allergies from an unknown date. There were no concomitant medications. The patient experienced anaphylaxis on an unspecified date in 2021. The patient had a little bit of an allergic reaction to the first dose of the Pfizer COVID 19 vaccine in 2021, it was not severe enough to use an Epipen. The shortness of breath from 22Jan2021 18:00 lasted over a week. Her lips were tingly from 22Jan2021 14:30, she could feel the end of her nose. Her throat was closing from 22Jan2021 14:30. She had pain in her arm from 22Jan2021 11:00, and her muscles ached from an unspecified date in 2021, the left side of her face, ear, throat and teeth hurt (facial pain from an unspecified date in 2021, ear pain from 22Jan2021 23:00, throat pain from an unspecified date in 2021, tooth pain from 22Jan2021 23:00), pain in left shoulder from 22Jan2021 20:30, pain in neck from 22Jan2021 23:00. She did have to take Benadryl for treatment of shortness of breath. She felt better after 1.5 weeks. The outcome of events anaphylaxis, allergic reaction, muscles ached, Facial pain, Throat pain was unknown, outcome of event pain in arm was resolving, outcome of event tooth pain was resolved on 23Jan2021, outcome of shortness of breath was resolved on 01Feb2021, outcome of other events was resolved on 24Jan2021.

Pain in left back/rib cage radiating to front of chest. No blistering rash yet. Patient also reports itching and burning sensations in affected area. Patient went to urgent care (2/25/21) and was diagnosed with shingles. Patient was prescribed valtrex.

Cos tongue tingling and possible rash. was taken to ED by RRT. She stated having flushing neck and cheeks, elevated blood pressure 138/115 to 140/73

body ache, head ache, nausea, diarrhea, weakness, muscle pain, moving body pain, food intolerance, thirst, shaking, feeling of crawling out of body. Lasted 3 1/2 days. Last 2 days shaking and crawling out of body feeling was not present. Diarrhea only day 1. Nausea lasted 1 1/2 days. Day 4 no adverse effects remained. Not certain if the above was related to vaccine but timing seemed to match.

Arm was sore at injection site for about 24 hours then the next day severe arm pain started. Within a few days it was painful to move my arm backward, upward and forward. The pain lasted over a week; I contact Primary Physician and he recommended ice and acetaminophen. I did that for several days and by day 10 it was spreading to my shoulder area and radiating down my arm. On 2/25 I went to urgent care (primary is 50 miles) and then my Primary is preparing consult for Ortho.

For about 20 minutes I experienced severe belly pains, profuse sweating and cold and clamminess, my temperature dropped to 93 degrees. When I finished with these symptoms my temperature climbed back up to 97.7. I have been having intermittent belly pains since then but they are nothing like they were last night and they are getting more mild and far between as I write this.

Experiencing swollen, very tender lymph nodes under armpit. Taking Tylenol for pain. Symptoms are getting better.

Sore arm, nausea, with in an hour of vaccine. fever 100.6 started couple hours later treated with Tylenol

Onset approx 45 min after injection--swollen eyelids and face, moderate throat constriction and hoarseness, severe fatigue, headache, brain fog for first 20 hrs, then intermittent eyelid and face swelling, hoarseness, fatigue and brain fog for the next 3 days, followed by mast cell activation symptoms of fatigue, puritis, and mild racing heart in the evening for the last two days. For the past 3 years I have been medication free and virtually symptom free. The symptoms of the last few days are consistent with those I had during the years when my MCAD was active. I am concerned that the vaccine has reactivated the hyper-sensitivity of my mast cells.

Tingling sensation on her fingertips, on the lower part of her face, and chin; Tingling in her tongue and lip; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 26Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 for COVID-19 immunization. The patient received the second dose of the COVID-19 vaccine in the morning of 26Jan2021. From that afternoon on (26Jan2021), the patient had tingling in her tongue and lip. The patient did not have this side effect before. The patient was also feeling it on the lower part of her face today (28Jan2021) and is also feeling a tingling sensation on her fingertips. The patient was now (28Jan2021) experiencing a tingling sensation on her tongue, lips, and chin and it doesn't go. The patient wanted to speak with someone to ask if this is a normal side effect or if she should be concerned. The patient was asking what she can do about this. The patient had not recovered from the events. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.

Body aches; Puttered around the house, then lost energy around noon; headache upon waking; felt like I had a hangover; Lethargic all day; Fever 99.5-100.2; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received second dose of BNT162B2 (lot number: El9265), via an unspecified route of administration on 29Jan2021 13:00 at single dose in the left arm for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included levothyroxine sodium (UNITHROID). The patient previously took first dose of BNT162B2 (lot number: El324) at the age of 62 year-old on 08Jan2021 13:00 in the left arm and experienced minor injection site soreness. On 30Jan2021 07:00, the patient experienced headache upon waking Saturday morning and felt like she had a hangover. She felt lethargic all day. She had fever 99.5-100.2 from 7pm- 9pm on Saturday night. She experienced body aches on Sunday morning, 31Jan2021. Puttered around the house, then lost energy around noon. She felt ok but not back to normal energy level yet. Stated she is going to work tomorrow. The patient was not pregnant at the time of vaccination. The patient did not receive any treatment for the events. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient underwent lab tests and procedures which included body temperature: 99.5-100.2 on 30Jan2021. The outcome of the events was recovered in Jan2021.

One day after vaccine severe body aches and sore arm. I had covid 19 in October 2020 and found the body aches after the vaccine to be worse than having the virus itself. Second day after vaccine I noticed lymph node in my armpit to be very swollen. This was the same side of my body the shot was given. I am worried about getting the second dose but I am still going to get it.

0430 AM WOKE WITH BURNING FEELING AND CHILLS. AT 0730 TEMP DONE SEVERAL TIMES. 104.9 ORALLY. CALLS MADE TO CLINIC AND PCP. I REFUSED TO GO TO EMERGENCY DEPT (HOSPITAL WAS TOTALLY FULL AND SOME). ALL DAY FEVER, NEVER BROKE. SAT. 102-103 SUN. WOKE FEELING FINE.

On or around December 22, I noticed pain in my left forehead as though someone had hit me with a baseball. The next week around the 29th, it got very noticeable - pain to the touch but no swelling. It continued. Between the first dose and second dose I didn't recover, it just stayed.

Very hyper talkative & negative on way home. Got home had anxiety attack. Went to bed at 4:00pm couldnt sleep ..suicidal thoughts/OCD negative thoughts,very depressed... got up at 6pm. Next day woke up with headache started to clean tired and depressed. Dizzy and tripping over my feet. Next day woke up with headache started to clean got very tense and lightheaded and weak. Had to sit. Husband took blood pressure and it was 70/50. took again diff arm same. Sat for 1/2 hr went to 100/74. Feeling weak all day. Very confused no memory. Went to bed took Seroquel to calm down and sleep. Add note: I have been depressed for a while but the drop in blood pressure, drop in mood(bad) and weakness and dizziness happened after shot. Im afraid to take the 2nd one because of how it affected my mood. and blood pressure.

Blood sugar rose to 501one hour after vaccine. It was 166 in the am Never has been that high Left arm vaccine rm tingled and numb all the way to finger tips

I am submitting this as a supplementary report to the report assigned on March 1, 2021. This is day 10 after the vaccine and my mast cell reactivity symptoms have increased by the day--internal and external swelling, flushing, pruritis, wheezing, tightness in chest, as well as pain and pressure in arm pits, groin, and ears. By late afternoon I am severely fatigued, weak, and foggy-headed. These symptoms are consistent with those I experienced during the twenty years when my mast cell disease was unstable. Through identification of my triggers and avoidance of the same, I have been symptom and medication free for the past three years--until taking the Covid-19 vaccine. It appears that the vaccine has reactivated an excessive degranulation response in my mast cells and that response is getting worse as my body responds to the vaccine. I realize that the percentage of persons who suffer from a condition like mine is small, but I would have appreciated having the information that I am submitting to you when I was weighing the pros and cons of vaccination. I know from the twenty years of navigating this disease that there is nothing that can be done at this point other than taking various H1 and H2 blockers. This vaccine appears to be undoing the hard-won level of stability achieved through years of careful lifestyle management.

My husband also had the same vaccine at the same time but did not experience my symptoms as described below: Vaccination was given very high on the should blade instead of upper arm of left arm. After the injection on 2/27/21 arm was mildly sore, but on the third day, there was more pain. On March 3, the pain was worse, very painful to lift or bend left arm, constant throbbing pain, there is no inflammation on the injection site but whole left arm especially the injection site is very very painful. To this day, March 5, 2021 the pain and throbbing persists, It is very painful to lift or bend the left arm. Will start take OTC CVS Ibuprofen 200 mg every 6 hours to ease the pain.

15-20 after vaccine was administered I felt very confused and couldn't remember where I put my card, my pocketbook, felt pretty disoriented. I remember someone telling me to sit down and eat something. (I had already had lunch and a snack). That evening I started to have a bad headache. Thursday morning I had a very difficult time getting up and was extremely fatigued; felt hot. I felt exhausted all day and looked pretty tired and pale. Friday morning still tired, had some bouts of energy, but they didn't last long. Body aches were worse and I also had some stomach discomfort Saturday felt like I had a sore throat, felt weak, and still pretty tired. I had some problems catching my breath when climbing stair and and at one point felt hot and clammy. Headache was better.

On day 10 I woke with achey shoulders, neck and hands. Later in day had mild chills and overall aches and by evening had 101.5 temp and flushing of face along with mild headache. Tylenol taken along with warm shower and early bed. Woke in am with mild headache, loss of appetite. Felt better by 11am and after a cup of tea. By afternoon I felt 100% back to normal. No rashes or even a sore arm post vaccination in the days prior to this event on day 10.

Within about 5 minutes after the injection, I experienced the following symptoms, in this order: 1) Light headedness 2) Increase heart rate 3) Hands tingling 4) Upper Lip numbness

About 7-8 hours after Vaccine (1st dose), I developed severe arm pain and could not lift my arm and noticed numbness/tingling in my right little finger. I went to bed and woke up at around 2:30 AM, I had very hot, stabbing, shooting pain running up and down my arm into my neck and upper shoulder. I also had pain running down my arm. This pain was a 9/10 and lasted for 3-4 hours non stop. I was up most of the night and considered going to the ED. The following day, I still had numbness/tingling in my right little finger. I was able to move my arm a little more but not enough. The numbness/tingling took 3-4 days to go away and the arm soreness took 5-6 days to go away. I received the shot from a Pharmacy Intern. I do have shoulder problems but this was not normal. I am a RN. I am very thin, weighing around 107 lbs. I wondered about the technique used or the length of the needle, or the possibility that I was allergic to something in the vaccine. I was also very, very tired for 2-3 days. I do have a sore arm after the flu vaccine but not like this. I will not be receiving the second vaccine, even though I am immunocompromised. I did call my MD office but did not go in.

Patient complained of tingling in the neck, shoulder & arms. onsite EMS was called vitals BP 168/78 96% O2. Diphenhydramine 25mg orally griven. she was monitored, felt better, released againt medical advice.

Rapid heart beat; jitteriness; fatigue; sore arm; This is a spontaneous report from a contactable health care professional (patient). A 62-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EN6201), via an unspecified route of administration on 05Feb2021 at 08:15 on the left arm at a single dose for COVID-19 immunization. Medical history included sleep apnea from an unknown date and unknown if ongoing and meningioma removal on an unspecified date, 3 years ago. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced rapid heart beat, jitteriness, fatigue and sore arm on 05Feb2021 at 10:00. The patient did not receive treatment for the events. The outcome of the events was recovering. The events were reported as non-serious.

Little chill; tired; felt like I have no energy/ My body feels so weak; slight pain on left arm/ my hand started to pain a lot; I couldn't even touch my own self it was so sensitive; may be I'm inflamed; nausea; severe pain/ my waist my back is so painful; My body feels so weak; my fingers and hand; It triggered the shingles pain in my back; It triggered the shingles pain in my back; had no appetite, I didn't eat; She just checked her pressure and its was 130/80, and now, because of the pain, it went up a little bit; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982, expiration date: May2021), via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunization. Medical history included shingles which she contracted in 2019, about one and a half years ago, it was a shingles on her back and lower back which she stated were the worst place for shingles has attacked, it left her with severe pain in both legs; diabetes; and high blood pressure. Concomitant medications included losartan, atenolol (a beta-blocker), and metformin for diabetes. The patient took the vaccine on 22Jan2021 and after about 2-4 days (Jan2021), she had a little chill and got very tired. She had to take care of herself. She was very tired not realizing it was the shot she took. She also felt like she has no energy. The patient was working from home but a lot of times, she was lying on the couch. Over the weekend (Jan2021), she had a slight pain on left arm. About a week or 8-10 days later (2021), she got very tired and couldn't even sit up. Her body was not itself. She started to feel like a bus rolling over her, like somebody took a baseball bat and beat her really bad. The patient uses her arm a lot and her hand started to feel a lot of pain. She couldn't even touch herself; it was so sensitive. She took paracetamol (TYLENOL) but it didn't work. She had celecoxib (CELEBREX) an anti-inflammatory, she thought she was maybe inflamed, but it didn't work. She had some diclofenac cream, she rubbed it, but it didn't work. The patient had shingles about a year and a half ago which was very bad. She just felt weak and didn't feel like herself anymore. She had a little bit of nausea and her whole body was really terrible. When she had the shingles, it left her with severe pain in both legs. She saw a neurologist and told her that she would have to take pregabalin (LYRICA) and it would go away. So, when she had severe pain last week, she took pregabalin but it didn't help. The patient took half of acetaminophen, oxycodone (PERCOCET) as she was not the person who takes pills, but it didn't work. Her body was so severe on Friday, it was not going away, the pain was there 24 hours. The patient has been experiencing this for 8-10 days now. She took one PERCOCET on Friday and had a slight relief and didn't took anything again. She kept rubbing the diclofenac cream, but it was not much of a relief. This morning, she has to work, she was sitting so she took PERCOCET. She is getting her second shot on Friday, 12Feb2021. She asked how she will feel after the second dose if she felt that way after the first dose, if the first shot was adequate, and if she should take the second dose. She stated that she didn't want to take the second dose. Her body felt so weak including her fingers and hand. It triggered the shingles pain in her back and felt like she was beaten up by someone. She has to lie down for the pain in her back. She also mentioned that she couldn't sit for so long as her waist and back were so painful. She was lying on a heating pad and ice and nothing was working. She even has a hard time getting up. She thought what happened was it triggered the shingles pain in her back and also left her with a problem under her feet. The shingles left her with some kind of damage when she took the shot. It was really bad. Her son was a physician and was concerned because last week, it got so bad, she didn't come out, she was in bed and bedridden from Friday to Sunday. She had no appetite, she didn't eat. The only thing that the patient had was diabetes and high blood pressure, but it was under control. She just checked her pressure and its was 130/80, and now, because of the pain, it went up a little bit, but before my pressure was like 120 something, over 68 or 72 it was always around the 60s and 70s. Since she was having this, it was a little high. The outcome of the events was unknown.

Presented with weakness, generalized, and mild sweating. per patient " I typically get weak and sweaty when I stand prolonged periods of time." patient states symptoms pre vaccination and continued after vaccine." patients symptoms improved after sitting in chair, no other symptoms.

Seven minutes after receiving the Pfizer Covid 19 vaccine the patient reported having the feeling of being high lasting 10 minutes, elevated heart rate, dizziness and weakness for 1-2 minutes length, blurred vision and "brain fog" lasting for about 24 hours

Significant joint pain; fatigue; left arm pain. - Joint pain lasted 3 weeks from 12/27/2021 - 1/19/2021; Called Dr. - telemed visit - 1/18/2021. I had not recovered from the adverse symptoms of first dose before getting second dose. I had the second dose on January 19, 2021 - had joint pain but I did so much easier than this first dose.

Significant neck pain and muscle spasm 48 hours after vaccination, aseptic meningitis 3 weeks after vaccination requiring hospitalization.

Three (3) days after receiving my second shot, I began to feel nauseous. Shortly after, diarrhea began and lasted for 24 hours. Then, I began to have the chills and a migraine-like headache. The migraine is still continuing past 24 hours.

8:58AM: Vaccine administered 9:10AM: Reported tingling in fingers of right hand 9:19AM: Reported tingling in fingers of right hand and burning of throat. CRNP notified and came to assess patient. Patient reported tingling in fingers of right hand but rest of right upper extremity felt fine. Having "upset stomach" and "throat soreness" which patient states she did not have prior to vaccine. She then stated her throat was burning. Able to drink water. Denied difficulty breathing or shortness of breath. Patient listed her allergies of Morphine and Percocet causing itching and scopolamine patch causing delirium. She reports taking all her prescribed medications this morning as well as 2 Tylenol. 9:29AM: Benadryl 25mg PO administered and patient continued to be monitored in observation area 9:44AM: CRNP reassessed patient and she stated she feels better and her throat was only sore and no longer burning 9:58 AM: CRNP reassessed. Patient states she is still feeling okay and would like to leave. MA walked with patient outside where patient got a taxi and was staying at her daughters house the rest of the day so she would not be by herself.

After 1 hour facial swelling; After 45 minutes cheeks red; After 30 minutes face felt very hot; Stronger pain at injection site than with yearly flu shot; This is a spontaneous report from a contactable consumer (patient, self-reported). A 62-year-old female patient (who was not pregnant at time of vaccination), received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided) via an unspecified route of administration, in Arm Left, on 25Jan2021 13:15, as single dose for COVID-19 immunization, at hospital. Medical history included Allergy to All pain relievers and anti-inflammatory drugs and over the counter, allergies to penicillin and Allergies to sulfites all types. Patient was not allergic to Keflex injections, but allergic to the pull form. Concomitant medications included amlodipine, fluticasone propionate (FLONASE), famotidine (PEPCID AC), calcium, colecalciferol (CALCIUM/VIT D) and one a day multi vitamin (within 2 weeks of vaccination). Patient previously took cefalexin (KEFLEX), Bacitracin, Neomycin, Lidocaine, Prednisone; had allergies with these all medications. Historical vaccine included influenza vaccine (FLU SHOT) and had Pain at injection site. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. After 30 minutes of vaccine, face felt very hot. After 45 minutes cheeks red. After 1-hour facial swelling. Took 1 Benadryl tablet after noticing swelling. Heat and redness then faded. Facial swelling reduced over the next 24 hours without more Benadryl. Stronger pain at injection site than with yearly flu shot, for which patient was not received treatment. Seriousness of the events was reported as non serious. Outcome of the events was recovered in Jan2021. Information on the lot/batch number has been requested.

Dramatic flu symptoms. Extreme chills freezing cold extremities, fever, aches insomnia nose discharge, loose stools, headache, light nausea but did not vomit. Still not feeling well. Symptoms have decreased and can now sit in a chair as apposed to lying in bed.

Inside of body felt like it was on FIRE!! Mouth burning! Heart racing with minimal movement, shortness of breath,

Arm Pain (injection side) ...Within 5 minutes of injection. Mild neck and torso stiffness...Began 2 hours and 40 minutes after injection. Wheezing...Began about 4 and a half hours after injection. Shortness of breath occurred overnight. 8 hours after injection. ...checked oxygen level at 93 Moderate widespread aching...8 hours after injection. 15 hours after injection...oxygen level at 88 15 hours after injection...Temperature of 99

Exactly 12 hrs after second injection I had 103 temperature, severe shakes and chills. Both knees and arms at the elbows swelled and the elbow and Lymph nodes on my right inner elbow are still swollen. I am just now able to grip anything with my Left hand. I had both vaccines in my right arm. I am predominantly left handed. This has affected my work asin which I am still working full time.

I received the 1st Covid vaccine dose on March 8 . Minor tenderness and fatigue 1st 2 days. Then on March 11 and still today, March 13, I have had tingliness on my face and chin and nausea. It seems to be getting worse and not better. I have been taking Benedryl. Is this normal or what should I do?

Patient received the vaccine and about 3 minutes after she described a warm flushing feeling when it was injected, and tingling. No shortness or breath or chest pain, patient was removed from cell and taken to the observation area, her chest was red and flush. her blood pressure at 1145 was 178/122 and heart rate 89 and pulse ox 95% in her let wrist, patient was placed on litter and laid down, she was observed . Follow up blood pressure at 1208 on her left wrist was, 167/112, HR 87, pulse ox was 99 on room air. Blood pressure check in her right wrist was 175/99 . Patient stated that her symptoms were resolving with additional observation. Patient was then placed on the edge of the bed for additional time and patient was released from observation at 1215.

About 2 AM all of the muscles in my arms, legs and torso started twitching. This continued until about 5 AM, at which time I dozed off. When I woke up (about 7:30 AM), I noticed that all of the twitching had stopped. It never returned.

After receiving my first Pfizer vaccine on 2.24.21 at 4:45 p.m., I felt well. I woke the next morning 2/25/21, and felt fatigue, arm was tender but not sore. Earlier that morning, I had an aura, but no migraine materialized. Around 10 a.m., I began to have chills, more fatigued, and sore muscles. Left work at 3 p.m. Arrived home, went to bed with temperature of 101.2. Took Tylenol. Friday, Fever was gone, felt fatigued, arm still tender, and had a headache. Took Tylenol. Did not go to work on 2/26/21. Saturday, 2/27/21, woke at 4 a.m., right arm where vaccinated was very sore, armpit very sore, and right breast very sore. Placed cool compresses on my breast, arm pit and arm where vaccine was given. Took Tylenol. Still fatigues, achy, with sore shoulder muscles. Sunday, 2/28/21, Vaccine arm still sore, with some soreness still in right breast area. Took Tylenol. 3/1/21, called Dr. Still a bit achy and arm still tender

The night of the injection, I had severe pain in my neck, back of my head and right arm. The pain was so severe that I could not move my head or arm all night. I took Advil but could not sleep from the pain. When I did manage to sleep, I would have horrible dreams. By morning, I was feeling better but still sore from my neck and arm. I felt very tired and rested the entire next day. Pain has not returned. It was very scary.

Approximately 15 minutes after vaccination, patient began feeling bumps on lip and swelling under jaw. Soon after, she felt flushed with itching in feet and swelling of feet. I observed a mild redness to face and upper chest. I saw no swelling of neck, lips or oral cavity. I ordered 25 mg. benedryl po be administered at 3:10 PM. A few minutes later, she felt tightness in chest. At that point (3:15 PM) an EMT tried to inject an Epipen but only left the pen in for less than 1/4 second before she withdrew the pen. I then administered another Epipen directly after and the pen was in her thigh for over 3 seconds. The patient was transferred light and sirens to ER. She received no further Epi in the ER and received steroids, benedryl, and famotidine according to the ER Resident. She was doing well 90 minutes after vaccination per Dr.

Serious swelling and tenderness in arm pit and side, upper back, lymph nodes in neck and back of skull. upper chest and back of neck with horrible headache, Fever of 101.4, chills but major sweating. Ear aches in both ears from headache. Stomach upset for 4 days and couldn't eat. Body aches. Sleeplessness. Very light headed couldn't think for 4 days.

The day after the vax (Friday) All day my arm hurt so badly I could hardly raise it up. Around 7:30pm, I got nauseous, a really bad headache and had really bad chills. I got two heating pads out, one for my arm and one to warm me up. It lasted ?til about 3am and then it was over. My arm is still a little tender, but otherwise I am back to "my normal".

she felt something in her foot (right foot) under the toes like she had sept on something like the lymph node down there was inflamed; the lymph node under her arm got inflamed; armpit swelling; her eyes was runny, sort of hurting like salt in her eye; her eyes was runny, sort of hurting like salt in her eye; arm was hurting where she got the vaccine in the right arm; she had a mucus plug and was bleeding; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that a 62-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 62-years, via an unspecified route of administration in right arm on 19Feb2021 at single dose for COVID-19 immunization. Medical history included hadn't had her period for 8 years. Concomitant medications were not reported. The patient historically received first single dose of BNT162B2 at the age of 62-years for COVID-19 immunization. Patient received the 2nd dose of the vaccine last Friday 19Feb2021, when she was driving home her eyes was runny, sort of hurting like salt in her eye, it was like that all evening she had to put a patch on her eye to help it. That same evening may arm was hurting where she got the vaccine in the right arm, and the lymph node under her arm got inflamed. The next morning on 20Feb2021 when she woke up she felt something in her foot (right foot) under the toes like she had sept on something like the lymph node down there was inflamed, but that went away. The armpit swelling has continued since the day of the vaccine. Now this morning in Feb2021 she had a mucus plug and was bleeding she haven't had her period for 8 years, every two days she had something new. Patient wanted to know what had been woken up in her body. Consumer added that she read on line that patients should wait for 5months before going to their doctor about the swollen lymph nodes because they might send the person for a test, mammogram and it may say they have cancer, in the clinical trials apparently some patients has issues with their lymph nodes and when they did testing it was found they had cancer, but it was not cancer it was the vaccine. Outcome of the event she felt something in her foot (right foot) under the toes like she had sept on something like the lymph node down there was inflamed was recovered/resolved in Feb2021; of the armpit swelling was not recovered/not resolved; while of remain was unknown. Information on lot/batch has been requested.

Difficulty breathing, fast heartbeat, tongue numbness, dizziness, edginess, chest heaviness starting within 1/2 hour. I am four days into symptoms. I still have some chest heaviness and still having asthma issues which includes coughing. I also had side effects of sore arm, chills, fatigue. Did not seek treatment. I had no idea how long this would last. I wish I would have read the paperwork for severe allergic reaction, but I didn't. I would have gone to the ER. I have suffered with this since Saturday.

Got the vaccine, and a few minutes or so she felt like a funny sensation up around/left side of her head, like something was crawling inside her head, like something bulging. Throbbing type pressure sensation. She did not say anything at the time, and went home. She went home and still felt the feeling on her head. She did also notice that her hot flashes got a little worse than usual. Had a sore arm for a couple of days. When she laid down at night she could feel that sensation/throbbing in her head a little more. She put a ice compress on it but could feel it a little bit, not as bad as it was as of today 3/16/21. She called the pharmacy on Wednesday 3/10/21 who advised her to go see her PCP. She went to the UC last Friday 3/12/21 as she could not see her PCP. They checked her scalp and did not see any rashes or anything, and advised her to take Motrin intermittently with Ibuprofen. She also told her to check back if she continued to have problems, but she decided to see her regular PCP.

Pfizer-BioNTech Covid vaccine, first shot developed a blood clot in a superficial vein the day after the vaccine, was diagnosed by a doctor as "superficial thrombophlebitis, pain swelling in leg. Treatment of ibuprofren started. Wondering if I should take my second shot which is scheduled for MArch 26

These started 31 hours after injection. Chills, Headache, low grade fever of 99.9 body aches, sore arm. On 3 rd day after vaccine, injection site became red, hot to the touch and swollen. A separate area from the injection site also became red, swollen and hot to the touch. 4 th day, injection site and random site became more swollen and began to grow together with intense itching. Still hot to the touch and red.

Whole body is sore like as if I just ran a mile and every muscle hurts. shoulder/injection site hurts. Legs especially hurt.

Person administering hit a vein and blood was dripping down. Sore arm, lump and dark bruise 1.5? across at injection site. Fatigue and body aches beginning 4 days after vaccination.

Started seeing her eye become bug eyes and hurting started to slur speech and not about to walk. Called her neuro doctor on 3-1-21 he said to take her to the eye doctor so I did. They told me her eyes are dry to put eye drops in. Called her neuro next day he told me to take her to the ER. They diagnosed her with Graves Disease and now she is showing symptoms of Graves Disease. She has never had any problem with her Thyroid. Had blood work done back on Jan 20th 2021

About 4 hours after injection I started feeling pins and needles in my hands and then I started feeling it all over. It would come and go. A few days later it felt like burning, stinging and itchy. I?m still getting it but not as frequently. There?s no rash. I?m concerned about getting a 2nd vaccine. I know this could be related to the vaccine or anxiety. I saw blogs that this happened to others after the Covid vaccine.

After my fourth day (March 16th) of the vaccine this is what happened: Day started great and about 1pm started having severe diarrhea with intervals of 15 to 30 minutes apart. At approximately 2:30pm I started having projectile vomiting. All of this lasted until approximately 5pm, I was also very clammy and cold, no fever. by 7pm I felt somewhat normal. The next day I felt great! It was an experience I've never had before so that why I am sending this to you!

March 13 was vaccinated at 2 PM and 12 hours later she began to feel twitching/shaking in all extremities associated with difficulty walking due to the "jerking twitching"..

tested positive for Rheumatoid Arthritis; body aches; muscle pain; joint pain; nerve pain; fingertips and toes were very painful-burning sensation; fingertips and toes were very painful-burning sensation; Underarm pain-throbbing; skin hurt when applying lotion; Low grade fever 99.9; This is a spontaneous report from a contactable other healthcare professional (patient). A 62-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9262), intramuscularly at right arm on 29Jan2021 11:00 at single dose for COVID-19 immunization at workplace clinic. The patient's medical history included autoimmune disorder, kidney disease, angina, and high blood pressure. There were other medications that the patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Known allergies: Simvastatin, Tramadol, Codeine. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283), at the age of 62-year-old, intramuscularly at right arm on 09Jan2021 13:15 at single dose for COVID-19 immunization at workplace clinic. It was reported that on the 2nd day after the vaccine (30Jan2021 13:00) patient started having body aches, muscle pain, joint pain, nerve pain. Her fingertips and toes were very painful-burning sensation. Also reported underarm pain-throbbing. Her skin hurt when applying lotion. Had low grade fever 99.9. Treatment was received for the above mentioned events: Tylenol 500mg, 2 Caps Q6h. Patient was recovering from the above mentioned events. She do have an autoimmune disorder: her Rheumatologist is checking for Psoriatic arthritis. She had tested positive for Rheumatoid Arthritis (unknown outcome). No treatment for this condition at this time. The patient was not pregnant at the time of reporting, not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 or not prior to vaccination. The patient had not been tested for COVID-19 since the vaccination.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 at 2nd injection cannot be excluded for the reported events based on the known safety profile and the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

About 6 hours after I got it, I felt tired. The next day, my arm was sore and my eyelids were swollen every day for about 5 days. I had aches and pain all over, itchiness, headache, joint pain over the next week. Around the 22nd, it stopped. It took almost 10 days for me to feel somewhat normal.

Extreme headache. Could not lift head off of pillow. Light bothered me and made headache worse. So tired could hardly stay awake.

I had arm pain, aches, tired and vomited a few time. I felt weird all over. I had pain in my upper abdomen, legs and lower back. Chills and anxiety. On 2/8, I had a tele visit with my doctor. I took Tylenol as instructed to make sure that I didn't develop a fever. My doctor said that it could be from the vaccine. My left leg and foot were swollen on 2/13, so I called my doctor again and he sent me for a Doppler to check for a blood clot. I saw him on 2/15 in person. I have lower back pain and weakness in my legs at times, but it doesn't prevent me from doing anything. They feel heavy, especially if I walk for an extended period of time.

My arm has remained sore since the shot 4 days ago. Specifically in the armpit but aches all the way down to my hand at time. My armpit is swollen and painful. The pain goes thru my underarm down to my hand. The pain makes it difficult to sleep. Tylenol doesn't take the pain away. At first I thought the pain was a side effect to the initial vaccine, but it got worse as time went on. Finally I researched it on line and saw that lymph nodes have been reported as swelling due to the vaccine.

Patient complaints as COVID vaccination as following; numbness, tingling, and cold sensations on left 4th finger. After 15-20 minutes later, the patient had full sensation, color, ROM, and temperature on all 4 fingers. No further medical intervention needed.

woke 8am on 3/17 with dull headache . 12 noon headache became worse. Took Acetaminophen 500 mg 1pm broke out in cold sweat and became nauseated. 1:30 began vomiting. Remained nauseated, cold sweats off and on, multiple episodes of vomiting until 5pm

3/22/2021 was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening . During the observation period, she experienced an adverse reaction with the following symptoms: rapid heart rate. And clammy Assessment : Time of assessment 1613 Alert and oriented. Actions taken: Vs taken at 1613 BP- 121/69 P- 72, water offered Medications administered: No medication administered. Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 3/22/2021 3:36 PM 0.3 mL 12/11/2020 Intramuscular

After 24-48 hours my cheeks looked flush, after 72 hours it was darker and had prickly bumps, after 96 hours bumps more pronounced with some small pimple sized and covering a larger portion of the cheeks . It was also warm to the touch and beginning to feel like a mild sunburn. It stayed this way until Monday morning , 6 days later when I contacted my doctor. Doctor instructed me to take benedryl and see if this relieves it. Also informed me to take benedryl before I get my next injection. It is still ongoing at this level at the middle of day 6 as I am submitting this report.

Facial swelling, red hot cheeks. I took one Benedryl tablet and heat & redness subsided. 24 hours later swelling was gone.

Large lump appeared in left armpit 3 days after Vaccine It is very sore to touch and hurts most of the day. Went to Dr. Told me to keep taking Tylenol and using a pain rub (Hemp Vana) on it. Said it should die down in 4 to 6 weeks.

Sever body aches including to touch skin throughout body. Sever pain shooting through body and muscle. Severe headache and lethargy. Swollen painful lymph node under left arm pit that continues...

complained of tingling in legs and itchy throat approximately 10 minutes after injection. Monitored in observation area and when symptoms didn't resolve after 30 minutes, transferred to triage 1 for observation and evaluation. 1330-BP 186/82, p-118, O2 sats- 98% Declined a Zyrtec 1337 BP 156/72, p-60, O2 sat-99%, no further tingling in legs. No scratchiness in throat. Denies difficulty swallowing, no shortness of breath, no swelling in mouth, lips or tongue. Evaluated by Dr., Patient released to home. Reviewed symptoms to seek care for- shortness of breath, trouble swallowing, difficulty breathing

high fever x 2 days, low grade fever x 1 day, fatigue, body aches, severe chills, shaking, brain fog x 4 days , injection site reaction - swelling and redness in entire L arm x 3 days, hot flashes with intense sweating.

pt had a seizure while waiting on observation area she reports her family was with her and told her about seizures medical staff alerted and 911 called. pt awoke from seizure and declined to go to ER reports she felt okay. unclear if generalized seizure.

1 week after 2nd dose, on 1/24/21, woke up with stiff neck (left rear cervical area) which proceeded with nerve pain down left shoulder and arm. After 2 weeks with no relief OTC remedies, saw PCP on 2/8/21, who ordered PT. Saw chiropracter for neck pain on 2/8/21. Weekly PT appts x 5 weeks, no relief. Saw PCP again on 3/5/21 for extreme nerve pain in arm. Prescribed Tramadol for pain, put on 11-day course of Prednisone. Some pain relief, but not resolved. MRI ordered and completed on 3/19/21 with no findings except arthritis. Now being referred to Spine Clinic for further diagnosis.

62 years old female called to report an adverse reaction after she received her first Pfizer dose on 03/18/2021 @1330. patient report that on 03/20/2021 @1030 she developed dizziness, lost balance, fever and shaking. patient denies any allergies. patient reported that she is taking Lyrica, Lamictal for facial nerve pain. and amitriptyline to help her sleep. patient was instructed to drink plenty of water and keeping hydrated to help with the dizziness, patient was instructed to take tylenol to help with the fever. patient was instructed to seek medical attention if the symptoms got worse.

Felt dizzy, had metallic taste in mouth. Numbness & tingling of lips, tip of tongue. Dizzyness got better after 15 minutes. Tingling of lips & tongue better after 1 hour, but still present. Face felt hot & flushed 40 minutes after shot. Also had some "burning" of veins in wrist . Metallic taste continues.. Some itching of face.

I have a complex history of anaphylactic reactions to many allergens. Immediate reaction to Pfizer vaccine #1--flushed/hot, strong metallic taste, chemical smell, tachycardia (156-158), nausea, some chest discomfort and dizziness. BP 158/85 (my normal is 100/60). O2 sats 98%. I did not feel anxious until heart rate would not come down to baseline. Clinic staff monitored me and did not treat. Allowed heart rate to decrease over time. Took over 20 minutes to get below 120. At 35 minutes, it was below 100. Stayed at clinic for one hour and released. Still had metallic taste (over 3 days now), loss taste, loss of appetite, headache, and fatigue.